I'm an independent QA/RA consultant for medical device companies. I help companies build and maintain their Quality Management Systems, prepare for audits, navigate regulatory requirements (ISO 13485, EU MDR, FDA 21 CFR Part 820, MDSAP), and handle post-market surveillance and vigilance obligations. I also write procedures, conduct supplier audits, provide training and much more.
Yes. Most of my work is remote and I serve clients internationally - Europe, North America, and beyond.
Yes, this is a large part of what I do. I help startups build their QMS from scratch, aligned to the regulatory requirements they need to meet for their target markets.
Both. I work as an embedded consultant alongside internal QA/RA staff, or as the only QA/RA resource for companies that don't have one in-house.
Both models work. Some clients hire me for a defined project (e.g., ISO 13485 gap assessment, SOP package, audit preparation). Others retain me on an ongoing monthly basis for continuous QA/RA support.
ISO 13485:2016, EU MDR 2017/745, EU IVDR 2017/746, FDA 21 CFR Part 820 (as well as 803, 806, 807, 830), and MDSAP. These cover the vast majority of what medical device companies need for international market access.
I can take you through the full preparation process - build your QMS or remediation, internal audits, readiness assessment, and pre-certification audit support. The certification itself is issued by an accredited certification body; I prepare you to pass it.
Yes. EU MDR transition and compliance work is a core service - QMS alignment to MDR requirements, PMS and vigilance procedures, regulatory documentation strategy, and audit preparation for notified body reviews.
ISO 13485 certification body audits, MDSAP audits, FDA and notified body inspections, and customer audits. I help companies prepare procedurally, conduct internal audits, and act as consultant during the audit itself.
Yes. I conduct remote and on-site supplier audits per ISO 13485 and applicable requirements, and deliver full audit reports with findings and follow-up recommendations.
I can help you analyze the finding, develop a CAPA plan, and build the corrective action documentation. For warning letters, I help clients understand the gap between current state and expected state, and build a remediation plan.