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  • shereenmurrah replied to the topic "ISO 14971 standard in risk management"4 years, 4 months ago

    The risk management plan consists of scope, responsibilities/authority, review reqs and criteria, risk verification, data collection and review (production and post-production).  The first 3 clauses are introductory and requirement clauses. clause 4: intended use and foreseeable hazards, estimated risk for each hazardous situation clause 5: evaluation…   Read more»