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I will be your risk management expert
Turning Medical Device Regulations into Practical, Clear Solutions!
I am a Certified ISO 13485:2016 Lead Auditor with 8+ years of experience in Quality Assurance & Regulatory Affairs for medical devices. I specialize in FDA 21 CFR Part 820, EU MDR, and ISO 14971:2019 ...
About this Gig
I will provide expert risk management consulting for medical devices to ensure FDA and EU MDR compliance. With deep experience in risk assessment, ISO 14971, and regulatory requirements, I offer practical solutions tailored to your product needs. This includes risk analysis, documentation support, and strategy implementation to help you meet global regulatory standards efficiently and confidently.
