Process Risk Assessment Model. Robert C. Menson, PhD. What Risks Must Be Managed?. Risk to safety of patients, users, handlers. Business. Regulatory. Product liability. Intended Use/Intended Purpose.
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Robert C. Menson, PhD
Risk to safety of
patients, users, handlers
ANSI/AAMI/ISO 14971:2000, definition 2.5
FDA Subcommittee on PAT Proposed Definition
Robert C. Menson, PhD 18