I will help you in technical documentation

I help medical device companies develop and remediate technical documentation in compliance with EU MDR (2017/745), ensuring readiness for regulatory submissions and audits. My expertise includes compiling Technical Files (Annex II & III), risk management documentation aligned with ISO 14971, and post-market surveillance systems. I also support the investigation and closure of audit findings through structured CAPA processes, focusing on thorough root cause analysis and sustainable corrective actions. My approach is risk-based and evidence-driven, delivering clear, traceable, and audit-ready documentation that reduces compliance gaps and strengthens regulatory confidence.