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We are needing an ISO 13485 and EU MDR Internal Audit in MD in June. They are looking at 3-days onsite with 1-day prep/report writing. 
Any auditors in that area who have availability in June?

Hi Trevor,

Thank you for sharing this opportunity.

I am not based in the Maryland area, so I may not be the best local option for this specific audit if proximity is a key requirement.

However, I would be interested in being considered for future audits where an international auditor is acceptable and where travel can be planned accordingly.

My background includes ISO 13485:2016, GMP/quality system auditing, and EU regulatory expectations, with a practical focus on audit readiness, QMS effectiveness, and inspection-relevant evidence rather than checklist-only auditing.

For ISO 13485 and EU MDR audits, I believe it is important to clarify the expected scope early, especially whether the focus is on the full QMS, technical documentation interfaces, post-market surveillance/vigilance, supplier controls, risk management, or management responsibility.

I would be happy to connect and remain available for future audit opportunities where my background may be a good fit.

Best regards,
Christian Schmidt
Founder & Principal Consultant
Schmidt GMP-Consulting
ISO 13485 | EU GMP | FDA | Swissmedic | Audit Readiness | Gap Analysis

Hello Trevor,

I am based in southeast Ohio (not Maryland but close depending on what part of Maryland you are in) if you are still looking for an auditor.  I have certification in both ISO13485 (lead auditor) and MDSAP (internal auditor) and am familiar with EU MDR reporting guidelines.  Most of my audits are for audit readiness and gap assessment but I have also been involved with building an eQMS for my current company (Arete Biosciences) so I am very familiar with requirements of the standards and regulations.  I was a bench scientist in R&D and Medical Device Manufacturing for nearly 20 years prior to QA and quality auditing.  Let me know if you are interested or keep me in mind for the next opportunity.

Regards,

-Nanda