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3) Document the outcomes of the Quality Plan in a Quality Plan Report Implementation of all requirements from the quality plan and any associated deviations or additions should be documented within the quality plan report.
All effectiveness checks required by the quality plan should be documented as well.
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Where appropriate, objective evidence of implementation shall be attached or referenced.
Implementation of the quality plan can potentially take several weeks to several months to complete and as such, a series of quality reports may be generated to document implementation in phases.
S.” As clarification, the new standard is identical to EN ISO 14907 (corrected version from October 01, 2007); however, this new edition contains information within Annexes ZA, ZB, and ZC that explains the differences between ISO 14971 and the expectations of the Medical Device Directive.
As a helpful hint, each of the annexes are specific to the three Directives (93/42/EEC, 90/385/EEC, and 98/79/EEC).
2) Generate a Quality Plan that addresses the gaps identified during the analysis The quality plan should first define the corrective actions to any nonconformances identified in the gap analysis from a risk management system/quality management system viewpoint (i.e. Next, the quality plan should consider the risk management files for all currently marketed products and any products currently in the design phase and define the specific tasks required to bring them into compliance with the systematic updates.
While it is true that conformance to the requirements in the EN annexes is mandatory only for medical devices marketed within Europe, medical device manufacturers should strongly consider conforming to the 2012 edition because the deviations (or differences) are a smart, conservative approach to evaluating risk.
From our experiences, a comprehensive approach is required for applying the 2012 standard to existing risk management systems and remediating risk management files for currently marketed products to comply with the new edition.
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