Complaint Handling Regulatory Guidelines
ZebraSci offers a complete portfolio of solutions to comply with regulatory expectations for life cycle management of medical devices. With a wealth of experience in the development, failure analysis and improvement of medical devices, our experienced team provides consultative support to help you ensure the safety of your devices.
21CRF820 Medical Devices Quality System Regulation (QSR)
- 21CFR820.198 Complaint Files
21CFR211 CGMP for Finished Pharmaceutical Products
- 21CFR211.198 Complaint Files
EUROPEAN COMMISSION DG Health and Consumers
- MEDDEV 2.12-1, GUIDELINES ON A MEDICAL DEVICES VIGILANCE SYSTEM
With our knowledge and experience in failure analysis, investigative laboratory testing and regulatory guidance’s, ZebraSci partners with our clients to mitigate the risks associated with commercializing medical devices.
Common Complaint Failure Modes
- Slow Injection Time
- Incomplete Injections
- Activation Failure
- Sterility & Integrity