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as934 replied to the topic kinds of changes in PM in the forum Project Management Process and Medical Device Development 7 years ago
Changes can be made to design control documents, SOPs, DMR, BOM, DID, DDP, DSD, verification/validation protocols, and the risk management plane. Changes will go through a design review process during which documents are reviewed, changes are made if necessary, and documents are approved. Once the document is approved, a controlled copy is updated and released.