The Biocompatibility Hub, medical devices live here.

Medical Devices Live Here

Connecting industry thought leaders, biocompatibility professionals - labs and consultants, and the public in an open forum community in order to foster consistency, idea sharing and forward thought. We strive to become the ultimate content library for everything biocompatibility, from material selection through submission.

Library Research Materials

Are you new to the arena and biocompatibility came as a surprise to you? Or, are you a veteran and a recent submission went sideways with requests or requirements that totally blind sided you? Are you keeping up on the ever changing standards landscape? We have provided generic summaries of the typical test methods for different guidelines as they have changed over the years. Our intention was not to infringe upon any copyrighted material, but to provide the information which is already out there via various protocols.

Interface With Suppliers

Linking Medical Device Manufacturers with parts and material suppliers, testing laboratories and regulators. If you would like to post your company's services for free, please let us know and we will work with you to get your logo, a description of the services you provide and a link to your home page or even specific pages in your website

Open Invitation Forums

Forums are available now for community use. We will moderate and provide input as often as we can, but this will hopefully become a user driven area of the site. The intention is to have a more consistent regulatory process. Users may post as themselves or anonymously since we know some subject areas are sensitive. We will never share your contact details.

Current Events

Current trade shows, work shops, conferences, communiques from regulators, and medical devices in the news.

Biocompatibility for Medical Devices US, this October in Chicago, will provide you with the latest insights into the guidance surrounding biocompatibility and ISO 10993. Put your questions to leading Competent Authority, Notified Body, TC/194 working group experts and industry representatives. Find out more here.

On June 16, FDA released the final version of the "Use of 10993-1" document which replaces G-95. There are changes from the original draft but the document is well written and includes much of FDA's current thoughts on medical device safety testing in general as well as individual tests and considerations for them. Click the link below to access the document.

Use of ISO 10993-1 2016

Recent Library Additions

FDA Guidance: Coronary, Peripheral, and Neurovascular Guidewires

FDA Recognized Consensus Standards Update

The Ten Steps to a Biological Evaluation within a Risk Management Process

Post-Approval Biocompatibility

ISO 10993-4 2017 review

ISO 10993-11 2017 review

White Paper
USP <88> vs. ISO 10993 Class Test

The Failed Cytotoxicity Test