This eBook contains guidelines for planning, risk mitigation, testing, and compliance for the design and manufacture of medical devices. It provides a digest of pressing challenges and solutions for medical-device design, development, and testing with regard to biocompatibility and toxicology planning, testing, and compliance. It is intended to serve as a guide for professionals and teams involved in quality assurance, quality control, quality engineering, R&D, regulatory affairs, manufacturing, and consulting in related areas.
Table of Contents:
- The New and Improved ISO 10993-12:2021: What Is Really Changing
- Understanding the EU Medical Device Regulation for Device Companies
- FDA Draft Guidance for Biocompatibility of Certain Devices in Contact with Intact Skin: the Naughty and Nice List
- 3D Medical Devices and Biocompatibility
- Medical Device Extractables and Leachables Testing in 2020
- Choosing Colorants for Medical Devices
- How to Address Failed Cytotoxicity Testing on Medical Devices
Read about the authors below.