I will do iso 14971 certification

I will provide professional ISO 14971 Certification Services, helping you implement, audit, and maintain a fully compliant risk management process that aligns with ISO 14971:2019 and regulatory expectations. Even though ISO 14971 is not directly a certifiable standard like ISO 13485, demonstrating conformity is essential for regulatory approvals. My services will help you pass audits, inspections, and notified body assessments with confidence.

will guide or facilitate risk analysis activities using internationally accepted tools:

• Design FMEA (dFMEA)
• Process FMEA (pFMEA)
• Use-related/UFMEA
• Fault Tree Analysis (FTA)
• Hazard Analysis (HA)
• Hazard and Operability Study (HAZOP)

I ensure thorough, systematic, and properly documented analysis so that all hazards, sequences of events, and harms are accurately captured.

Expertise You Can Trust

I bring deep knowledge of ISO 14971, ISO 13485, EU MDR, IVDR, and international regulatory frameworks. My experience helps streamline your risk management processes and ensure they meet global expectation