The eQMS for
medical device companies.

Specialties offered by the firms in the Expert Network include EU MDR 2017/745 and IVDR 2017/746 strategy and CE marking, ISO 13485 quality management, ISO 14971 risk management, FDA pathways (510(k), De Novo, PMA, QMSR), PRRC services (Article 15 person responsible for regulatory compliance), clinical evaluation, post-market surveillance and vigilance, labeling, validation and software compliance (IEC 62304, cybersecurity), audits and training. The directory is growing.

MoniDoseQMS is built by Monidose Oy in Finland and hosted in the EU. The Expert Network is open to regulatory and quality consultancies from any country; regulated companies can filter the expert directory by specialty and region, and consulting firms can apply to join at monidoseqms.com/for-experts/apply. The product interface is in English.

MoniDoseQMS is a cloud-based electronic Quality Management System (eQMS) for regulated industries, with medical device companies first (including IVD and software as a medical device). It brings 130+ integrated modules — document control, CAPA, audits, risk management, training, supplier quality, design controls, post-market surveillance, EU AI Act records, and a REST API with signed webhooks — into one integrated platform, replacing a patchwork of separate tools and spreadsheets.

It is designed for regulated industries, medical devices first: device manufacturers (Class I, II, and III), in-vitro diagnostics (IVD), Software as a Medical Device (SaMD), AI/ML-enabled devices, and contract manufacturers and research organizations in the same space. Its modular design suits both startups standing up their first QMS and established manufacturers consolidating onto one platform.

MoniDoseQMS is built to support ISO 13485:2016, EU MDR 2017/745, FDA QMSR, 21 CFR Part 11 (with open items we track openly), ISO 14971, IEC 62304 and the EU AI Act, with template-based support for EU IVDR and IEC 62366-1. These are self-assessed supports, not certifications, and you remain responsible for your own compliance.

Pricing is published and modular, in EUR excluding VAT. Each plan is a flat monthly price with an included-user allowance: Foundation €49 (up to 10 users), Growth €79 (up to 50 users) and Enterprise €129 (unlimited users). On top come the required Core QMS base (€499/month) and only the module bundles you choose (€79 to €349 each). The cheapest paid setup is therefore Foundation plus Core QMS at €548/month. Your final price is confirmed in your quote. See https://monidoseqms.com/pricing.

You can request a 14-day trial of the core QMS modules for up to 3 users (1 GB), with no credit card. We activate your workspace after a short review, so it is not instant. Request it at https://monidoseqms.com/contact?interest=trial, or book a 30-minute demo at https://monidoseqms.com/demo.

MoniDoseQMS includes 130+ integrated modules, sold in 14 bundles. You enable and pay for only the capability areas you need, so the system scales from a lean startup setup to full enterprise coverage. Each module has its own detail page at https://monidoseqms.com/modules.

Yes. MoniDoseQMS is fully modular. The required Core QMS provides document control, CAPA, and the essentials, and you add only the bundles relevant to your products and target markets. This keeps the platform affordable and avoids paying for capabilities you will never use.

No software is validated in the abstract: you validate it for your intended use, and we support you. MoniDoseQMS is designed to support 21 CFR Part 11, with electronic signatures that capture meaning, reason, time and IP address, password re-authentication, and a tamper-evident, SHA-256 hash-chained audit trail. Part 11 support has open items that we track openly (for example, failed signature attempts are not yet written to the audit trail). We provide a customer validation guide with IQ/OQ/PQ protocol templates (currently a draft, shared under NDA) to support your validation.

Customer data is hosted in the EU (EEA) on infrastructure operated by Monidose Oy, a company based in Akaa, Finland. Connections use TLS 1.2 or higher, database backups are AES-256 encrypted every 6 hours and copied off-site, and tenants are separated by PostgreSQL row-level security. We act as your GDPR processor and a data processing agreement is available on request. MoniDose does not currently hold ISO 27001 or SOC 2 certification; see https://monidoseqms.com/security.

MoniDoseQMS includes 12 dedicated EU AI Act modules covering AI system inventory, AI risk assessment, data governance, technical documentation, transparency, human oversight, conformity assessment, and post-market monitoring — to manage the records for your own AI systems, including AI/ML-enabled medical devices. MoniDoseQMS itself does not include AI features.

Book a 30-minute demo at https://monidoseqms.com/demo, or request a 14-day trial at https://monidoseqms.com/contact?interest=trial (activated after a short review, no credit card). For questions, contact info@monidoseqms.com; we reply within one business day.

Yes. MoniDoseQMS includes the Expert Network — an expert marketplace built into the eQMS. Approved regulatory and quality consultants publish a firm profile, get discovered in a customer-facing directory, work inside their clients' live quality systems through consent-gated access (read-only by default, which the customer can widen per engagement), leave structured recommendations, and track hours and invoices from one expert workspace. Consultants can serve unlimited clients and apply at https://monidoseqms.com/for-experts/apply.

Companies using MoniDoseQMS can find a regulatory or quality expert in the built-in directory and open a scoped engagement without leaving their QMS. The expert receives access only while the customer grants it and only to the records the customer scopes; access is logged and revocable. The expert's recommendations are tracked in the system, and an expert can never approve alone: regulated approvals and signatures stay with the customer's own team. Details at https://monidoseqms.com/for-experts.