Tim Stokes

Medical Device Development Consultant @Viatris

MedicalBioengineerProduct ConsultantProduct DesignerEngineer🐦 DesignStartup Founder

Experienced consultant in medical devices, IVDs, SaMD and combination products with expertise in ISO 13485, FDA 21 CFR 820, EU MDR and IVDR compliance. Strong background in DHF remediation, design control, requirements engineering, user needs validation and verification and validation planning. Skilled in TMV, Gage R&R, FMEA (dFMEA, pFMEA, uFMEA), usability engineering to IEC 62366, IEC 62304 software compliance and risk management to ISO 14971. Proficient in Polarion ALM, Helix ALM, Windchill and Agile/DevOps environments with proven success in system and subsystem V&V, post market surveillance trending, technical file updates and regulatory submissions.

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