Medical Devices
eQMS for medical devices, from design control to end of life.
Medical device companies need more than a digital QMS. They need design controls, risk management, supplier oversight, clinical trial management, regulatory submission management, and post-market surveillance connected to the same source of truth.
Frameworks
Built for the standards that govern medical devices.
FDA Medical Device Regulations
Medical devices QMS standard
Sterilization Standards
European medical device regulations
Medical Device Single Audit Program
Risk management for medical devices
Use cases
One platform across the device lifecycle.
Design controls & risk management
Link user needs, design inputs, design outputs, verification, validation, and risk management files so that a design change automatically surfaces affected records.
Document control & training
Keep procedures, work instructions, and workflows under revision control with read-and-acknowledge training workflows.
CAPA & complaint handling
Connect complaints, nonconformities, and CAPAs with traceability back to the product family, procedure, and supplier.
Post-Market Surveillance (PMS)
Consolidate vigilance, adverse events, and periodic safety update reports instead of managing them in separate systems.
Supplier & audit management
Track supplier qualifications, audits, nonconformities, and the approved supplier list with automated escalation when certificates expire.
Submissions & registration tracking
See how a change to a 510(k), CE technical file, or IDE affects your quality system and post-market obligations.
Why it matters
Post-market surveillance is part of the QMS, not an afterthought.
Under EU MDR and FDA requirements, vigilance and complaint data must feed back into risk management, CAPA, and labeling. When PMS lives in a separate tool, that feedback loop breaks. A continually monitored compliance platform built for medical devices keeps the loop intact.
- Adverse event reporting linked to product family
- Risk file updates triggered by complaint trends
- CAPA traceability from complaint to closure
- Periodic safety updates generated from live data
Ready for your first 510(k), CE mark, or MDSAP audit?
IntelaSolve gives medical device teams an audit-ready quality system out of the box — with the regulatory and post-market connections most eQMS platforms leave out.