ISO 13485 & GMP Medical Device Consulting
The medical-device standard. Built for FDA expectations, MDR compliance, and a quality system that ships product safely.
Quality systems for medical devices
ISO 13485 is the international quality standard for organizations that design, develop, manufacture, install, or service medical devices. It aligns with FDA’s 21 CFR Part 820 and is required for CE marking under EU MDR. GMP (Good Manufacturing Practice) is the underlying expectation for safe, consistent production.
Certification gives you market access in the EU, recognition in many other regions, and a defensible system in the face of FDA inspections.
Who needs ISO 13485?
Device manufacturers
- Class I, II, III medical devices
- Combination products
- OEM and contract manufacturers
Suppliers to device makers
- Component suppliers required by their customers
- Sterilization, packaging, and labeling vendors
- Software-as-a-medical-device (SaMD) developers
Companies expanding internationally
- CE marking under EU MDR
- Health Canada MDSAP
- Other regulated markets (Japan, Brazil, Australia)
Our approach to ISO 13485
The same four-step path that has put 300+ audits in the win column.
- 1
Gap analysis
Current state vs. ISO 13485:2016 and applicable GMP. Risk-based prioritization.
- 2
Implementation
Design controls, risk management (ISO 14971), CAPA system, post-market surveillance — integrated into your operations.
- 3
Internal audit
Full QMS internal audit, management review, and corrective-action cycle.
- 4
Certification audit support
Stage-1 and stage-2 audit support with notified body or registrar of your choice.
What you get
ISO 13485 quality manual & procedures
Tailored to your device class, scope, and regulatory targets.
Design control system
DHF, design inputs / outputs, verification, validation, design transfer.
Risk management file (ISO 14971)
Hazard analysis, risk evaluation, risk-control matrix, residual risk.
CAPA & non-conformance system
Investigation methodology, root-cause framework, effectiveness checks.
Post-market surveillance program
PMS plan, complaint handling, vigilance reporting, MDR readiness.
Internal audit & certification audit support
One audit cycle plus stage-1 and stage-2 support.
Ready for your ISO 13485 certification?
Tell us about your device, your regulatory targets, and your timeline. The first conversation is free.
Start Your Audit-Ready Plan Today