ISO 14971:2019 & Design Controls Master Toolkit

A complete, editable risk management pack: Risk Management SOP, Risk Management Plan and Report templates, an Excel hazard analysis / dFMEA / pFMEA workbook with automatic risk scoring, a DHF traceability matrix, and a 62-slide ISO 14971 training deck with speaker notes.

• 62-slide ISO 14971 & design controls master deck (PPTX) with speaker notes
• Excel workbook: hazard analysis, dFMEA, pFMEA with auto risk scores and colour zones
• Risk Management SOP (Word)
• Risk Management Plan template (Word)
• Risk Management Report template (Word)
• DHF index & design traceability matrix (Word)