The Medical Devices Biocompatibility Testing eBook is officially available! Buy it now!


Biocompatibility Testing of Medical Devices

Medical device biocompatibility can be challenging at times for both professionals or new comers to the regulatory industry. Often it seems like a complex array of tests needs to be completed which is both time consuming and expensive. Often medical device companies find themselves wondering if 1) they need to do biocompatibility testing and 2) what type of testing can be done to speed up the overall regulatory process without compromising device and patient safety. The Biocompatibility testing eBook is a great guide for manufacturers and regulatory individuals who are looking to understand the theory and practical aspects of device testing.


The book provides a great introduction into understanding medical devices and the influence of technological trends as well as how to overcome simple barriers when choosing medical devices.

  • Chapter one to three provides insight into what is biocompatibility testing and do medical device companies really need this type of testing. It further covers how manufacturers can determine if they should be testing their device and how to determine what tests apply.
  • Chapter four provides an overview of various biomaterials and an understanding into the difference between in vivo and in vitro testing. It also covers the importance of testing with GLP.
  • Chapter five provides an in-depth understanding of how to prepare your sample. Chose the appropriate extraction media and extraction conditions. It also covers how to select a suitable reference material and experimental controls.
  • Chapter six and seven are your bonus resources! Here you’ll find templates of a biological evaluation plan and biological evaluation report with prompts on how to complete them ad what information you should be entering. You’ll also find some commonly asked questions by device manufacturers.

This 130-page resource is a must for all regulatory individuals who really want to understand the theory behind biocompatibility testing.

Buy the Medical Devices Biocompatibility Testing Book now!