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This comprehensive resource covers product change evaluation, postmarket surveillance, audit/inspection compliance, and various other laws and regulations pertaining to maintaining a product on the market.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
Chapter 1: Introduction and History
Chapter 2: Regulatory Requirements for Design & Process Validation
Chapter 3: Risk-Based Verification and Validation
Chapter 4: The Need for Test Method Validation
Chapter 5: Test Method Validation for Medical Devices and Packaging
Chapter 6: Design of Experiments
Chapter 7: Sterilization Validation Principles
Chapter 8: Six Sigma Concepts in Validation Studies for Medical Device Packaging
Chapter 9: Medical Packaging Validation
Chapter 10: Cleaning Validations of Medical Products
Chapter 11: Software Validation for Life Sciences
Chapter 12: FDA Unique Device Identification Verification and Validation
Chapter 13: Equipment Validation
Chapter 14: Sample Sizes for Verification and Validation
Chapter 15: Verification and Validation in Medical Device Computational Modeling and Simulation
Chapter 16: Additive (3D Printing) Manufacturing
Chapter 17: Cybersecurity and Data Integrity
Chapter 18: Validating the Medical Device Laser Welding Process
Chapter 19: Start-up of Cleanrooms, Initially and After a Worst-Case Event
Appendix A: Quality Management Systems - Process Validation Guidance
Appendix B: Design Control Guidance for Medical Device Manufacturers
Appendix C: Reporting of Computational Modeling Studies in Medical Device Submissions
Appendix D: Technical Considerations for Additive Manufactured Devices
Appendix E: Data Integrity and Compliance With CGMP
The new chapters discuss the need for test method validation, device test method validation, design of experiments, additive (3D printing) manufacturing, cybersecurity and data integrity, validation of the laser welding process and the set-up of cleanrooms, both initially and following a worst-case event. Updated chapters include, among others, the history of device validation and validation of design, sterilization, packaging, cleaning, software and equipment.