Built for Regulated
Industries
MoniDoseQMS is built for medical device companies first, with the same modules available to related regulated sectors, plus the regulatory experts and notified bodies (pilot programme open) that serve them.
Book a 30-min demoMedical Devices
ISO 13485, EU MDR and FDA QMSR support for Class I, II, and III devices. Design controls, risk management, clinical evaluation, and post-market surveillance in one platform.
Drug-Delivery & Dose-Dispensing Devices
The MoniDose namesake. Dedicated verification modules for dose-dispensing and drug-delivery devices — dosing accuracy testing, battery safety, dispenser usability studies, and device-specific risk management — alongside the full medical device QMS.
In Vitro Diagnostics
IVDR support through templates plus risk, clinical and regulatory-affairs modules for diagnostic manufacturers.
Digital Health & SaMD
Software as Medical Device lifecycle management, IEC 62304 lifecycle records, cybersecurity assessment, and EU AI Act records for digital health companies.
AI/ML-Enabled Devices
12 dedicated EU AI Act modules. AI system inventory, risk assessment, data governance, transparency, and post-market monitoring.
Combination Products
Cross-functional document control and integrated risk management for products spanning both drug and device regulatory frameworks.
Regulatory & Quality Consultancies
Serve every client from one expert workspace. Get discovered in the customer-facing directory, work inside clients' live QMS with consent, and run advice, hours and invoicing in one place.
Pharmaceuticals
Batch records, deviations, environmental monitoring and supplier quality for GMP environments. This is record-keeping support, not a GMP clause-by-clause mapping.
Biotechnology
R&D documentation, design development, lab sample management, software validation, and clinical investigation support for biotech companies.
Contract Manufacturing
Supplier qualification, process validation, equipment calibration, and batch records for CMOs.
Contract Research
Clinical investigation management, regulatory submissions, training records, and document control.
Laboratory Services
Lab sample tracking, method validation, equipment calibration, environmental monitoring, and competency management for regulated laboratories.
Cosmetics & Personal Care
Document control, complaint handling, supplier quality and training records, using the generic QMS modules.
Food & Beverage
Generic QMS modules only: audits, supplier management, non-conformances, CAPA and training. No food-safety scheme mapping.
Veterinary Devices
Veterinary device makers can run the same ISO 13485-based QMS even where no device regulation applies. Market-specific requirements are yours to confirm.
Not sure which modules your device needs?
Try the free classification tool and Regulatory Guide, or book a 30-minute demo and we will walk through your device class and markets.