I will audit your medical device qms to iso 13485 and eu mdr

United Kingdom

I speak English

5 orders completed

"I help businesses work smarter with AI and deliver polished content"

Struggling to find someone who delivers professional quality fast? I'm Fereg — a compliance professional with 10+ years working with global medical device companies, now combining deep expertise with ...

About this Gig

Is your Medical Device QMS Audit-Ready for ISO 13485 & EU MDR?

Don't risk non-compliance. I am a BSI-certified Internal Auditor and Senior QA/RA Manager with over 15 years of hands-on experience in manufacturing, compliance, and regulatory submissions.

I specialize in providing rigorous internal auditing services that verify the effectiveness of your Quality Management System against the toughest global standards. My reports don't just find faultsthey give you the actionable data needed to prepare for Notified Body and Competent Authority inspections.

What is included in this comprehensive Gig? I will act as your remote Internal Auditor, delivering a thorough inspection focused on systemic compliance.

Audit Planning: I will create a formal, risk-based Audit Schedule/Plan tailored to your specific QMS scope.
Custom Checklists: Preparation of detailed audit checklists covering all relevant clauses and regulatory requirements:

ISO 13485:2016 (Core QMS Structure)
EU MDR 2017/745 (Technical Documentation, PMS, PMCF, UDI, PRRC requirements)
ISO 9001:2015 (General Business Quality Management)