130 Modules, 13 Categories
Browse every module in MoniDoseQMS. Click any module to see what it does, which regulations it covers, and how it connects to the rest of your quality system.
Document Control & Quality
15 modules
The core of your QMS: controlled documents and SOPs, 21 CFR Part 11 electronic signatures, change control, deviations and non-conformances, CAPA and preventive actions, record archival, and the quality metrics — KPIs, cost of quality, SPC — that keep you audit-ready.
Document Management Hub
Centralize all quality documents in a single, secure hub with powerful search, categorization, and lifecycle management. Ensure every team member always accesses the latest approved version while maintaining full traceability across your entire document ecosystem.
Document Control
Manage the entire lifecycle of quality documents with version control, electronic signatures, and automated workflows. Ensure every SOP, work instruction, and form meets regulatory requirements with a fully auditable document management system built for regulated industries.
SOP Template Library
Accelerate SOP creation with a curated library of industry-standard templates designed for regulated environments. Reduce drafting time and ensure consistency across your organization with templates aligned to ISO 13485, EU MDR, and FDA requirements.
CAPA Management
Track and manage all corrective and preventive actions with built-in root cause analysis tools. Ensure every CAPA follows a structured workflow from identification through effectiveness verification, with full audit trail and regulatory-ready documentation.
Preventive Actions
Proactively identify and eliminate potential quality problems before they occur. Systematically analyze trends, near-misses, and risk indicators to implement preventive measures that strengthen your quality system and reduce costly corrective actions.
Deviation Management
Capture, investigate, and resolve deviations from established procedures with a structured workflow that ensures nothing falls through the cracks. Classify deviations by severity, conduct thorough investigations, and drive timely resolution with full regulatory traceability.
Non-Conformance Reports
Document, investigate, and disposition non-conforming products and materials with a clear, regulatory-compliant workflow. Ensure proper segregation, evaluation, and resolution of non-conformances while maintaining complete records for audit readiness.
Electronic Signatures
Achieve full 21 CFR Part 11 and EU Annex 11 compliance with validated electronic signatures. Provide tamper-evident audit trails, user authentication controls, and meaning-based signatures that satisfy the most rigorous regulatory expectations.
Record Archival
Securely archive quality records with configurable retention policies that meet regulatory requirements. Ensure long-term accessibility and integrity of your quality records while maintaining compliance with FDA, EU MDR, and ISO 13485 retention mandates.
Notes
Capture and share quality-related observations, meeting minutes, and informal notes within a structured, searchable system. Keep institutional knowledge accessible and linked to relevant quality records without the overhead of formal document control.
Change Control
Manage every change to your products, processes, and quality system through a structured, risk-assessed workflow. Ensure all changes are properly evaluated, approved, and implemented with full traceability to affected documents, training, and regulatory submissions.
Quality KPIs
Define, track, and report on key quality performance indicators that give leadership clear visibility into quality system health. Drive data-informed decisions with real-time dashboards and trend analysis across all quality processes.
Cost of Quality
Quantify and track the financial impact of quality activities, failures, and improvements across your organization. Make the business case for quality investments by measuring prevention costs, appraisal costs, and failure costs with clear, actionable metrics.
Performance Evaluations
Evaluate and document the performance of your quality system processes against defined objectives and acceptance criteria. Ensure continuous improvement by systematically measuring process effectiveness and identifying optimization opportunities.
SPC Charts
Monitor process stability and capability with statistical process control charts that visualize production data in real time. Detect trends, shifts, and out-of-control conditions early using industry-standard control chart methods and Western Electric rules.
Audits & QMS Governance
5 modules
Plan and run internal and external audits, capture findings in audit reports, hold management reviews, track a compliance calendar, and log quality events across the organization.
Audit Management
Plan, execute, and track internal and external audits with configurable checklists and finding management. Generate audit reports and ensure every observation is linked to corrective actions for complete regulatory traceability.
Audit Reports
Generate professional, regulatory-compliant audit reports with consolidated findings, observations, and recommendations. Streamline report creation with structured templates that ensure consistency and completeness across all your audit activities.
Compliance Calendar
Never miss a regulatory deadline with a centralized compliance calendar that tracks all your quality system activities, submissions, and renewal dates. Get proactive notifications and maintain visibility into upcoming obligations across your entire organization.
Management Reviews
Conduct structured management reviews with comprehensive input data aggregation and output tracking. Meet ISO 13485 management review requirements with pre-built agendas, automated data collection, and documented action items that drive continuous improvement.
Quality Events
Capture and manage all quality events in a unified system that routes each event to the appropriate process whether it becomes a deviation, CAPA, complaint, or non-conformance. Ensure no quality issue is lost and every event receives timely investigation and resolution.
Risk & Vigilance
6 modules
Manage product and process risk to ISO 14971, handle complaints and adverse events, and run field safety notices and recalls — the full risk and post-market vigilance loop.
Risk Management
Implement a complete ISO 14971-compliant risk management process from hazard identification through post-production monitoring. Maintain living risk management files with dynamic risk matrices and full traceability to risk controls and verification activities.
Complaint Handling
Capture, investigate, and resolve product complaints with built-in regulatory reporting workflows. Ensure timely investigation and link every complaint to risk assessments and CAPA actions for continuous improvement and full regulatory compliance.
Adverse Event Reporting
Report and track adverse events with workflows aligned to global regulatory requirements including EU MDR vigilance and FDA MDR reporting. Ensure timely submissions to authorities and maintain complete records of every reportable event.
Field Safety Notices
Prepare, approve, and distribute field safety notices efficiently when corrective actions in the field are required. Manage the entire FSN lifecycle from drafting through distribution tracking, ensuring affected customers and authorities are notified promptly.
Recall Management
Coordinate product recalls and field safety corrective actions with a structured process that ensures rapid response and complete traceability. Track affected units, manage customer notifications, and document the entire recall from initiation through closure.
Dispenser Risk Management
Apply risk management to dispensing and drug delivery devices with specialized hazard analysis addressing dose-related risks, device-drug interactions, and patient use errors. Maintain risk management files that address the unique risk profile of dispensing devices.
Design & Development
4 modules
Run design projects through the full design-control lifecycle — inputs, outputs, configuration items, and label masters — with traceability from requirement to verification and validation.
Configuration Items
Track and manage the configuration of your products, systems, and critical components throughout their lifecycle. Maintain a clear record of what changed, when it changed, and why, ensuring full traceability for regulatory compliance.
Design & Development
Manage the complete design and development lifecycle from user needs through design transfer. Maintain full traceability between design inputs, outputs, verification, and validation activities as required by FDA QMSR and ISO 13485.
Design Projects
Organize and track design and development projects with milestone planning, task management, and team coordination. Keep complex product development on schedule while ensuring all design control deliverables are completed and documented.
Label Masters
Manage master label designs and labeling specifications with version control and regulatory compliance checks. Ensure all product labels, IFUs, and packaging meet UDI requirements and applicable regulatory standards before release to manufacturing.
Validation & Verification
12 modules
Validation and verification end to end: process, software, and method validation, shipping validation, lab samples, and specialized device testing — dosing accuracy, EMC/EMI, biocompatibility, interoperability, battery, and alarms.
Lab Samples
Manage laboratory samples from receipt through testing and disposition with full chain-of-custody documentation. Track sample status, testing assignments, and results to ensure accurate, timely laboratory operations that support quality and production decisions.
Validation Management
Plan, execute, and maintain process validations with structured protocols, results documentation, and revalidation tracking. Demonstrate that your manufacturing processes consistently produce products meeting predetermined specifications and quality attributes.
Method Validation
Validate and verify analytical and test methods to demonstrate they are fit for their intended purpose. Document method accuracy, precision, specificity, and robustness in structured protocols that meet ICH, ISO, and pharmacopeial requirements.
Shipping Validation
Validate shipping and transportation processes to ensure products maintain their quality and integrity during transit. Document packaging qualification, temperature excursion studies, and transit condition monitoring for regulatory compliance.
System Validation
Validate computerized systems and automated equipment with structured protocols that meet 21 CFR Part 11 and EU Annex 11 requirements. Document your system validation lifecycle from requirements through testing to ensure regulatory compliance for all quality-critical systems.
Software Validation
Validate software used in quality and manufacturing processes with a risk-based approach aligned with FDA guidance and GAMP 5 principles. Ensure all quality-critical software is properly validated and maintained in a compliant state throughout its lifecycle.
Biocompatibility Testing
Plan and track biocompatibility testing programs as required by ISO 10993. Document biological evaluation strategies, test selections based on device contact nature and duration, and maintain complete records of all biocompatibility test results.
EMC/EMI Testing
Manage electromagnetic compatibility and electromagnetic interference testing programs for electronic medical devices. Track test plans, laboratory results, and compliance with IEC 60601-1-2 and other applicable EMC standards.
Interoperability Testing
Plan and document interoperability testing for connected medical devices and health IT systems. Ensure your devices communicate effectively and safely with other systems in the intended use environment, with testing records that support regulatory submissions.
Alarm & Notification Testing
Validate alarm systems and notification mechanisms for medical devices in accordance with IEC 60601-1-8. Document alarm priority assignments, testing protocols, and results to ensure alarms function correctly and safely in clinical environments.
Dosing Accuracy Testing
Plan and document dosing accuracy tests for dispensing and drug delivery devices to demonstrate they deliver the correct dose within acceptable tolerances. Maintain structured test records that support regulatory submissions and ongoing performance verification.
Battery Safety Testing
Document and track battery safety testing for portable and battery-powered medical devices. Ensure compliance with IEC 62133 and relevant safety standards with structured test protocols covering abuse testing, thermal performance, and transportation safety.
Production & Operations
19 modules
Day-to-day manufacturing and operations: work orders, batch and lot tracking, product release, equipment qualification and calibration, maintenance, environmental monitoring, distribution, and inventory movements.
Return Material Authorizations
Manage the return of products from customers or the field with structured authorization workflows and full traceability. Track returned materials from request through disposition, linking returns to complaints, investigations, and quality records.
Finished Goods Inventory
Track finished products from final release through distribution with lot-level traceability and hold/release controls. Manage warehouse locations, shipping holds, and distribution readiness to ensure only approved products reach customers.
Internal Transfers
Document and track the movement of materials, components, and products between internal locations, warehouses, and production areas. Maintain chain-of-custody records and ensure transferred items retain their quality status throughout your facility.
Manufacturing Records
Create and maintain Device History Records (DHR) and batch manufacturing records that document every step of your production process. Ensure complete traceability from raw materials through finished product release with records that satisfy regulatory requirements.
Process Management
Define, document, and monitor your manufacturing and quality processes with clear process maps and performance metrics. Ensure process consistency and compliance with documented procedures while identifying opportunities for optimization.
Work Orders
Create, schedule, and track production work orders with material requirements, routing instructions, and quality checkpoints. Manage your production workflow from order creation through completion with full visibility into status and resource utilization.
Batch & Lot Tracking
Track products and materials at the batch and lot level throughout your entire supply chain. Maintain complete forward and backward traceability from raw materials to distributed finished products, essential for investigations, recalls, and regulatory compliance.
Product Release
Manage the final release of finished products with structured review and approval workflows that verify all quality requirements have been met. Ensure no product ships without proper inspection, testing, and documentation completion.
Sterilization Equipment
Manage sterilization equipment, cycles, and validation records for sterile medical device production. Track sterilization parameters, biological indicator results, and equipment qualification to ensure every sterilization cycle meets validated requirements.
Environmental Monitoring
Monitor and control cleanroom and production environment conditions to ensure products are manufactured in compliant conditions. Track particulate counts, temperature, humidity, and microbial levels with automated alerting when limits are approached or exceeded.
Environmental Waste
Track and manage waste generated by manufacturing and laboratory operations in compliance with environmental regulations. Document waste streams, disposal methods, and quantities to maintain environmental compliance and support sustainability initiatives.
Calibration Management
Schedule, track, and document the calibration of all measurement and test equipment to ensure accurate and reliable results. Maintain calibration records, certificates, and traceability to national standards as required by ISO 13485 and cGMP.
Equipment Qualification
Manage the qualification of manufacturing and laboratory equipment through structured IQ/OQ/PQ protocols. Document that equipment is properly installed, operates correctly, and performs consistently to support validated manufacturing processes.
Maintenance Management
Plan and track preventive and corrective maintenance activities for all production and laboratory equipment. Minimize downtime and ensure equipment reliability with scheduled maintenance programs, work order tracking, and maintenance history records.
Cleaning Validation
Plan, execute, and document cleaning validation studies to demonstrate that your cleaning procedures effectively remove residues from equipment and manufacturing surfaces. Maintain validated cleaning records that meet FDA and EU GMP expectations.
Continuous Process Verification
Monitor manufacturing process performance on an ongoing basis to ensure processes remain in a validated state. Collect and analyze production data to detect trends and shifts before they result in out-of-specification products or quality issues.
Receiving Inspections
Inspect and verify incoming materials, components, and products against defined acceptance criteria. Document receiving inspection results and manage material dispositions to ensure only conforming materials enter your production and inventory systems.
Distribution Records
Track the distribution of finished products to customers and markets with complete lot-level traceability. Maintain distribution records that enable rapid identification of affected customers in the event of a field action or recall.
Service & Installation Records
Document service activities, installations, and field maintenance performed on your devices at customer sites. Maintain complete service records that track installations, repairs, preventive maintenance, and software updates for installed-base management.
Suppliers & Purchasing
3 modules
Qualify and monitor suppliers with scorecards and contracts management, and keep purchasing under control with full traceability.
Contracts Management
Manage quality agreements, service contracts, and regulatory obligations with lifecycle tracking and renewal management. Ensure contractual requirements are met and maintain full visibility into all quality-related commitments across your supply chain and partnerships.
Supplier Management
Qualify, monitor, and evaluate suppliers with risk-based assessment frameworks and structured evaluation processes. Ensure your supply chain meets quality requirements with approved supplier lists, qualification workflows, and ongoing performance monitoring.
Supplier Scorecards
Evaluate supplier performance with structured scorecards that measure delivery, quality, responsiveness, and compliance metrics. Drive supplier improvement through data-driven assessments and maintain objective records for regulatory and audit purposes.
Products & Materials
7 modules
Manage products, materials, bills of materials, inventory and assets, safety data sheets, and controlled medication storage.
Safety Data Sheets
Manage and distribute safety data sheets for chemicals, materials, and hazardous substances used in your manufacturing and operations. Ensure compliance with GHS requirements and give your teams instant access to critical safety information.
Product Management
Maintain a complete, centralized product registry with detailed specifications, classifications, and lifecycle status tracking. Ensure every product is properly documented with regulatory classifications, intended use statements, and links to all associated quality records.
Bill of Materials
Define and manage product bills of materials with multi-level component structures and version control. Maintain full traceability from finished products down to raw materials, ensuring accurate BOMs support manufacturing, quality, and regulatory requirements.
Material Management
Track and manage all raw materials, components, and consumables used in your products and manufacturing processes. Maintain material specifications, certificates of conformity, and supplier information in one place for complete material traceability.
Asset Tracking
Track and manage physical assets including equipment, tools, and fixtures across your facilities. Maintain complete asset records with location tracking, maintenance schedules, and qualification status for regulatory compliance.
Inventory Management
Manage inventory levels of raw materials, components, and work-in-progress with lot-level traceability. Ensure material availability for production while maintaining the quality controls and documentation required in regulated environments.
Medication Storage
Monitor and document medication and product storage conditions to ensure compliance with specified storage requirements. Track temperature, humidity, and other environmental parameters across storage areas with automated alerting for excursions.
Clinical & Post-Market
13 modules
Clinical evaluation and post-market evidence: literature reviews, clinical investigations, benefit-risk analysis, post-market surveillance, PMCF plans and reports, and PSUR — all linked back to your technical documentation.
Benefit-Risk Analysis
Systematically evaluate the clinical benefits of your products against their residual risks to support regulatory submissions and market access decisions. Document your benefit-risk determination in a structured format that meets EU MDR and global regulatory expectations.
Clinical Investigations
Plan and manage clinical investigations for medical devices with structured study management covering protocol development, site management, and regulatory submissions. Ensure your clinical studies meet ISO 14155 and EU MDR requirements from start to finish.
Clinical Evaluations
Conduct and document clinical evaluations as required by EU MDR and MEDDEV 2.7/1 Rev 4. Systematically assess clinical data from literature, clinical investigations, and post-market surveillance to demonstrate safety and performance of your devices.
Literature Reviews
Conduct systematic literature reviews to support clinical evaluations, risk management, and post-market surveillance activities. Document your search strategies, screening criteria, and analysis results in a structured format that meets regulatory expectations.
PMCF Plans
Develop Post-Market Clinical Follow-up plans that define your strategy for proactively collecting clinical data after market placement. Meet EU MDR Annex XIV Part B requirements with structured PMCF plans that identify methods, milestones, and evaluation criteria.
PMCF Evaluation Reports
Document the results of Post-Market Clinical Follow-up activities with structured evaluation reports. Analyze PMCF data to confirm ongoing safety and performance and identify any emerging clinical risks that require action.
PMCF Reports
Generate comprehensive PMCF reports that summarize all post-market clinical follow-up activities and findings. Create regulatory-ready documents that demonstrate ongoing clinical data collection and analysis as required by EU MDR.
PMS Evaluations
Conduct periodic post-market surveillance evaluations that aggregate and analyze data from complaints, vigilance reports, literature, and other sources. Identify trends and emerging issues to support proactive quality and safety management for your marketed devices.
Post-Market Surveillance
Establish a proactive post-market surveillance system that meets EU MDR Articles 83-86 requirements. Aggregate data from complaints, vigilance reports, literature, and registries to generate PMS plans and reports that demonstrate ongoing product safety monitoring.
PSUR Reports
Generate Periodic Safety Update Reports as required by EU MDR for Class IIa, IIb, and III devices. Compile comprehensive safety data, trend analyses, and benefit-risk conclusions in a structured format ready for submission to regulatory authorities.
PSUR Evaluations
Evaluate Periodic Safety Update Report data to assess the continued safety and performance of your marketed devices. Document evaluation findings, conclusions, and any required actions to maintain an up-to-date safety profile for your products.
Customer Satisfaction Surveys
Collect and analyze customer satisfaction data to drive quality improvement and meet ISO 13485 customer feedback requirements. Design, distribute, and analyze surveys that provide actionable insights into how your products and services meet customer expectations.
Dispenser Clinical Evaluations
Conduct clinical evaluations specific to dispensing and drug delivery devices, addressing unique considerations such as dose accuracy in clinical settings, patient handling, and combination product requirements. Meet EU MDR and FDA expectations for clinical evidence.
Regulatory Affairs
19 modules
Everything you need to reach and stay on the market: technical documentation, UDI and GUDID, declarations of conformity, CE marking, EUDAMED, notified-body management, registrations, and regulatory intelligence.
ISO Templates
Access a comprehensive set of ISO-compliant document templates that cover the full scope of your quality management system. Save weeks of preparation with templates structured to meet ISO 13485, ISO 14971, and other critical standards out of the box.
Post-Registration Review
Evaluate changes to registered products to determine if regulatory submissions or notifications are required. Streamline your post-registration review process to ensure changes are assessed against global regulatory requirements before implementation.
Inspection Readiness
Stay prepared for regulatory inspections at all times with a centralized readiness dashboard and structured preparation checklists. Identify gaps before inspectors arrive and ensure your team is confident, organized, and audit-ready.
Implant Cards
Generate and manage implant cards as required by EU MDR Article 18 for implantable medical devices. Ensure patients receive the required identification information including device details, UDI, and essential safety information.
Device Master Records
Compile and maintain Device Master Records (DMR) containing all specifications, procedures, and instructions needed to manufacture your products. Ensure your DMR is complete, current, and readily accessible for production and regulatory purposes.
Site Security Plans
Develop and maintain site security plans that protect your manufacturing facilities, products, and intellectual property. Document access controls, threat assessments, and emergency procedures to ensure physical security compliance for regulated production environments.
Product Registrations
Track and manage product registrations across multiple global markets with status monitoring and renewal tracking. Maintain a centralized registry of all regulatory approvals, clearances, and registrations to ensure your market access is always current.
UDI Records
Manage Unique Device Identification records and ensure compliance with FDA UDI Rule, EU MDR UDI requirements, and other global UDI mandates. Maintain accurate device identifier data and keep your UDI database submissions current across all required markets.
GUDID Submissions
Prepare and track submissions to the FDA Global Unique Device Identification Database. Ensure your device listing information is accurate, complete, and submitted on time to maintain compliance with FDA UDI requirements.
Declarations of Conformity
Create, manage, and maintain EU Declarations of Conformity as required by EU MDR Article 19. Ensure your DoC documents are complete, accurate, and updated whenever changes affect conformity, with templates that cover all required elements.
CE Marking Procedures
Document and manage your CE marking conformity assessment procedures aligned with EU MDR Annex IX-XI. Track conformity assessment routes, notified body interactions, and ensure all prerequisites are met before applying the CE mark to your devices.
Essential Requirements
Demonstrate compliance with EU MDR Annex I General Safety and Performance Requirements through structured checklists and evidence mapping. Maintain a living GSPR checklist that links each requirement to supporting evidence in your technical documentation.
Technical Documentation
Compile and maintain technical documentation files as required by EU MDR Annex II and III. Organize all required elements including device description, design information, risk management, and clinical evidence in a structured format ready for notified body review.
Regulatory Submissions
Plan, prepare, and track regulatory submissions across global markets including 510(k), PMA, EU MDR, and other submission types. Manage the entire submission lifecycle from planning through authority review and approval with complete documentation.
Economic Operators
Manage economic operator information as required by EU MDR including manufacturers, authorized representatives, importers, and distributors. Maintain up-to-date records ensuring compliance with EU MDR Article 30-34 obligations for all parties in your distribution chain.
Regulatory Commitments
Track and manage all regulatory commitments made to authorities, notified bodies, and other regulatory stakeholders. Ensure every promise and condition of approval is documented, assigned, and completed on time to maintain your regulatory standing.
Regulatory Intelligence
Stay informed about regulatory changes, new guidance documents, and evolving requirements that impact your products and quality system. Track regulatory developments across global markets and assess their impact on your compliance obligations.
EUDAMED Reports
Prepare and manage data submissions to the European Database on Medical Devices (EUDAMED). Ensure your device registrations, certificates, clinical investigations, and vigilance data are accurately reported to EUDAMED as required by EU MDR.
Notified Body Management
Manage all interactions with your notified body including applications, audits, certificate tracking, and correspondence. Keep your notified body relationship organized and ensure all certificates, conditions, and obligations are properly tracked and addressed.
EU AI Act Compliance
12 modules
A dedicated suite for the EU AI Act: AI system inventory and registrations, AI risk and conformity assessment, data governance, human oversight, transparency records, post-market monitoring, and incident reporting.
AI System Inventory
Maintain a comprehensive inventory of all AI systems within your organization, classified by risk level as defined by the EU AI Act. Ensure complete visibility into where AI is used in your products and processes, supporting compliance planning and regulatory readiness.
AI System Registrations
Manage registrations of high-risk AI systems in the EU database as required by the EU AI Act. Track registration status, maintain accurate registration data, and ensure timely submissions to demonstrate compliance with EU AI Act registration obligations.
AI Risk Assessment
Conduct and document risk assessments for AI systems aligned with EU AI Act requirements. Identify, analyze, and evaluate risks specific to AI including bias, transparency, accuracy, and robustness to ensure your AI systems meet regulatory safety expectations.
AI Conformity Assessment
Manage conformity assessment procedures for high-risk AI systems as required by the EU AI Act. Document compliance with essential requirements and prepare for third-party assessments where required, ensuring your AI systems can be legally placed on the EU market.
AI Data Governance
Document and manage data governance practices for AI training, validation, and testing datasets as required by the EU AI Act. Ensure your AI data practices meet requirements for data quality, representativeness, bias examination, and privacy compliance.
AI Human Oversight
Document and implement human oversight measures for high-risk AI systems as mandated by the EU AI Act. Define oversight roles, intervention capabilities, and monitoring procedures to ensure humans can effectively supervise AI system operation and outcomes.
AI Technical Documentation
Compile and maintain technical documentation for AI systems as required by EU AI Act Annex IV. Document system design, development methodology, capabilities, limitations, and performance metrics in a comprehensive format ready for regulatory review.
AI Transparency Records
Maintain transparency records that document how your AI systems make decisions and the information provided to users and affected persons. Meet EU AI Act transparency obligations by ensuring appropriate disclosure of AI system use, capabilities, and limitations.
AI Post-Market Monitoring
Implement post-market monitoring for AI systems to ensure continued compliance and performance after deployment. Track AI system behavior, collect performance data, and identify issues that require corrective action, as mandated by the EU AI Act.
AI Incident Reporting
Report and manage AI system incidents as required by the EU AI Act, including serious incidents involving harm or risk to health, safety, or fundamental rights. Ensure timely reporting to authorities and thorough investigation of all AI-related incidents.
AI Quality Management
Establish and maintain a quality management system for AI operations as required by the EU AI Act for providers of high-risk AI systems. Ensure your AI development, deployment, and maintenance processes meet structured quality requirements with proper documentation.
AI Fundamental Rights Assessment
Conduct fundamental rights impact assessments for high-risk AI systems as required by the EU AI Act. Evaluate how your AI systems may impact fundamental rights including non-discrimination, privacy, and human dignity, and document mitigation measures.
Software & Cybersecurity
4 modules
For software and connected devices: software lifecycle to IEC 62304, anomaly management, cybersecurity assessment, and over-the-air update control.
Software Lifecycle
Manage the complete software development lifecycle for medical device software in compliance with IEC 62304. Track software requirements, architecture, implementation, testing, and maintenance activities with the rigor required for regulated software development.
Software Anomalies
Track and manage software anomalies including bugs, defects, and unexpected behaviors throughout the software lifecycle. Ensure all anomalies are properly documented, assessed for risk impact, and resolved with full traceability as required by IEC 62304.
Cybersecurity Assessment
Assess and manage cybersecurity risks for connected medical devices throughout their lifecycle. Document threat models, vulnerability assessments, and security controls as required by FDA cybersecurity guidance and EU MDR cybersecurity expectations.
OTA Update Management
Manage over-the-air software updates for connected medical devices with regulatory-compliant change assessment and deployment tracking. Ensure every software update is properly evaluated, validated, and deployed with full traceability and rollback capability documentation.
People & Competence
8 modules
Build and prove competence: the training hub and sessions, competency assessments, a skills matrix, customer and patient training, and usability studies.
Training Management
Ensure every team member is qualified and current on required procedures with automated training assignments and competency tracking. Maintain a complete training matrix that satisfies ISO 13485 competence requirements and regulatory expectations.
Training Sessions
Plan, schedule, and track instructor-led and virtual training sessions with attendance management and completion verification. Coordinate training across teams and locations while maintaining detailed records of who attended, what was covered, and competency outcomes.
Training Hub
Provide your team with a centralized learning portal where they can access assigned training, track their progress, and view their competency status. Empower employees to stay compliant with an intuitive self-service training experience.
User Experience & Usability
Plan and document usability engineering activities as required by IEC 62366-1. Manage use specifications, user interface evaluations, and summative usability testing to demonstrate that your devices can be used safely and effectively by intended users.
Competency Assessments
Evaluate and document employee competencies against defined role requirements with structured assessment methods. Ensure your team has the knowledge, skills, and abilities required by ISO 13485 and demonstrate competency through evidence-based evaluations.
Skills Matrix
Visualize and manage team capabilities with a comprehensive skills matrix that maps employee competencies to role requirements. Identify skill gaps, plan training investments, and ensure adequate coverage for all critical quality and production functions.
Patient & Customer Training
Develop and manage training programs for patients, customers, and end users of your devices. Document training content, delivery methods, and completion records to ensure safe and effective device use as required by regulatory standards and labeling commitments.
Dispenser Usability Studies
Plan and document usability studies for dispensing and drug delivery devices with a focus on safe dose preparation, administration, and patient self-use scenarios. Ensure your devices can be used correctly by intended users including patients and healthcare providers.
Need help choosing the right modules?
Use our free Regulatory Requirements Finder to discover exactly which modules your organisation needs based on your product type and target markets.