Our Services
Medical Device QMS Audits (ISO 13485).
In medical devices, a supplier's quality system is your regulatory exposure. We audit it before the market — or an authority — does.
ISO 13485 is the backbone of medical device quality management and the reference point for regulatory frameworks including the EU MDR. Our auditors assess manufacturers and critical suppliers against its requirements: design and development controls, risk management per ISO 14971, production and process validation, sterilization and cleanroom controls where applicable, traceability and device history records, CAPA, and post-market feedback loops. Typical engagements are supplier qualification audits, pre-certification gap assessments, and ongoing surveillance of critical suppliers.
Innovio maintains an extensive network of auditors specialized in this field — available across Europe and beyond, matched by sector experience and audit history.
Capabilities
What's included.
Regulatory-Grade Auditing
Audits mapped to ISO 13485 clauses with MDR-relevant emphasis, by auditors with medical device manufacturing experience.
Process Validation Review
IQ/OQ/PQ evidence, sterilization validation, and cleanroom monitoring records examined in depth.
Supplier Qualification
Structured initial and surveillance audits for critical component and contract manufacturers.
Gap Assessment
Pre-certification readiness review with a prioritized closure plan.
How we work
Our process.
Scope & regulatory context
Device class, markets, and applicable requirements defined.
Audit
On-site or hybrid, records plus production observation.
Report
Clause-by-clause findings with objective evidence within 48 hours.
Corrective action & surveillance
Closure verification and scheduled re-audit.
Deliverables
- Clause-mapped audit report with objective evidence
- Risk management and validation review findings
- Supplier qualification recommendation
- Gap-closure plan with priorities
Standards & Codes
Industries served
Ready to start your medical device qms audits (iso 13485) project?
Talk to our engineering team to scope the work, agree the schedule, and receive a fixed quotation — usually within two working days.
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