Michelle Hilling

I help medical device manufacturers get and stay compliant, fast. I deliver FDA QMSR, EU MDR, ISO 13485 and EUDAMED programmes for Class I to III manufacturers across the US, EU and UK markets.

I am an ISO 13485 / EU MDR / FDA 21 CFR 820 / QMSR Lead Auditor with 12+ years in the sector, including Class III cardiovascular implants and Class II/III implantable silicone.

My track record is a 100% audit pass rate across 20+ engagements with zero major findings.

What I am usually brought in to do: QMSR transition and 21 CFR 820 gap analysis and remediation; EU MDR technical documentation, GSPR mapping and Clinical Evaluation; EUDAMED actor and device registration, UDI-DI and EMDN classification; ISO 14971 risk management; Notified body finding remediation, and complaints, vigilance and CAPA.

I work hands on across the full quality system and handle Notified Body and Competent Authority responses directly.

Recent example: closed 16 of 16 QMSR gaps for a Class I orthopaedic manufacturer in 34 days, with zero major findings, ahead of timeline.

I scope tightly and prove value early, so you see results before committing to more.