Innovio now audits medical device manufacturers and their critical suppliers against ISO 13485. Engagements cover the parts of a quality management system that decide whether a device holds up: design and development controls, risk management per ISO 14971, production and process validation with the IQ/OQ/PQ evidence behind it, sterilization and cleanroom controls where they apply, traceability and device history records, CAPA, and the post-market feedback loop.
Three engagement types account for most of the demand — supplier qualification audits before a component maker or contract manufacturer is approved, pre-certification gap assessments with a prioritized closure plan, and scheduled surveillance of suppliers already in the chain. Reports are clause-mapped with objective evidence and delivered within 48 hours.
ISO 13485 is also the reference point for regulatory frameworks including the EU MDR, which is why audits are run by auditors with hands-on medical device manufacturing experience rather than generalists working from a checklist. Innovio audits and verifies; certification against the standard is issued by accredited certification bodies.
Read the full Medical Device QMS Audits description, or get in touch to discuss a supplier qualification or gap assessment.