Module 14 2022

21/03/2022

Stats in medical device development

• Regulatory bodies require attainment of certain level of statistical significance during the development and testing of medical devices utilizing valid statistical techniques and rationale Process Validation • FDA: CFR Title 21 – Part 820 • ISO 13485:2016

The Organisation for Professionals in Regulatory Affairs

Statistical Considerations in Medical Device Clinical Investigations

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Stats in design & development toolkit

• To ensure that all statistical regulatory requirements for medical devices are met, statistical procedures are utilized in:

• Process Validation • Design Verification • Component/Material Qualifications • Design Validation • Audits and Effectiveness Checks • Test Method Validation • Manufacturing Acceptance Sampling Plans and Inspections • Trending Data • Setting Specifications

The Organisation for Professionals in Regulatory Affairs

Statistical Considerations in Medical Device Clinical Investigations

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