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- Medical Device Product Performance Specification Procedure
Medical Device Product Performance Specification Procedure
The Medical Device Product Performance Specification Procedure provides a process for documenting product requirements in the form of a product performance specification (P-Spec) in accordance with requirements of ISO 13485:2016, FDA QSR and MDR (EU) 2017/745. The procedure includes a detailed P-Spec Form/Template.
- ISO 13485:2016 Compliant
- FDA QSR Compliant
- MDR (EU) 2017/745 Compliant
- MS Word Format
- Instant Download - Digital Content
Product Performance Specification ProcedureThe Medical Device Product Performance Specification Procedure provides a process for documenting product requirements in the form of a product performance specification (P-Spec) in accordance with requirements of ISO 13485:2016, FDA QSR and MDR (EU) 2017/745. The procedure includes a P-Spec Form.
Product Performance Specification Procedure - OverviewThe Medical Device Product Performance Specification Procedure outlines the process for development of technical specifications and assigns departmental responsibilities to P-Spec development tasks.
The procedure outlines 16 critical product considerations (e.g. Indications for use; clinical procedure; patient interface; equipment interface; physical characteristics; etc.) and includes questions for each consideration to aide development teams. Product Performance Specification Procedure -ComplianceThe Medical Device Product Performance Specification Procedure is ISO 13485:2016, 21 CFR Part 820 and MDR (EU) 2017/745 compliant.
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