The Medical Devices Introductory Course 2020

Implement Quality Systems

Quality System Regulations (“QSRs”) [21 CFR 820]

• Apply to all devices (excluding specific elements for some “Exempt Devices”) • Includes requirements for: – Management Responsibility – Design Controls – Document Controls – Purchasing Controls – Identification and Traceability – Acceptance Activities – Non-Conforming Product – Corrective and Preventive Action (CAPA) – Labeling and Packaging Controls – Handling, Storage, Distribution and Installation – Records (including Complaint Handling) – Servicing – Statistical Techniques • QSRs apply post-market but also need to be in place for clinical supplies and product development (use of design controls and human factors) • FDA inspections (periodic or for cause) conducted against QSRs FDA Proposals issued considering possible replacement of FDA QSRs for ISO 13485: 2016

Development & Testing

Key stages of medical device development and testing per FDA CDRH Innovation White Paper:

Risk Managemen t throughout

Key data requirements for device development / submissions: • Laboratory / bench testing • Biocompatibility testing • Sterilization validation • Shelf-life and device lifetime testing • Software validation • Clinical testing [Illustrative list - non-exhaustive and not all necessarily required]

Design Controls apply in the shaded design + development and investigational phases