Preliminary GAP Assessment Report – Mega Bio Pharma Risk Management File Reviewed Findings/Gaps/Deficiencies Assessment/Recommendations for Improvement against EN ISO 14971:2012 and Documents MDD:M5 Annex I regulatory requirements BIONACRE_PGR_rev0 1....
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Preliminary GAP Assessment Report – Mega Bio Pharma Risk Management File Reviewed Findings/Gaps/Deficiencies Assessment/Recommendations for Improvement against EN ISO 14971:2012 and Documents MDD:M5 Annex I regulatory requirements BIONACRE_PGR_rev0 1. Section 1 General 0 draft-ENG – Risk Missing reference to applied risk management - Please include reference to risk management standard and version e.g. EN ISO 14971:2012 Management Plan standard and version e.g. EN ISO 14971:2012 and specific requirements for animal tissue derivatives ISO 22442-1:2015. Medical devices Section 3.4 section a) utilizing animal tissues and their derivatives -- Part 1: Application of risk Missing reference to QMS EN ISO 13485 including Management. design and development. Missing reference to Clinical Evaluation - Risk Management output is considered design input and input into the Clinical Evaluation Please provide a Section titled related processes. 2. Section 2 Responsibilities Responsibilities in
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