on 25 April 2013 | By Ryan Kasun
FDA issued a new draft guidance document on biocompatibility on Tuesday April 23, entitled Use of International Standard ISO-10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing. It is intended to replace the ODE General Program Memorandum #G95-1. G95-1...
Read Moreon 13 December 2012 | By Ryan Kasun
I sat down tonight, as I do every night that I write a blog post, and I started reading the prior posts from my colleagues. I had every intention of writing on a different topic tonight, but something struck a chord with me when I looked through the blogs. They all had something...
Read Moreon 12 December 2012 | By Ryan Kasun
I’ve been working in regulatory for a company in which biocompatibility of device materials has been pretty straightforward and understood by all for many years. Annex A in ISO 10993-1 and FDA General Program Memorandum - #G95-1 is all you need. Check the chart for our device...
Read MoreGLOBAL BOTTOM CTA INSTRUCTIONS:
To display custom copy instead of global copy in this section, please go to Show Global Content for Bottom CTA? toggle in the "Contents" tab to the left, toggle it off, save, and then REFRESH the page editor, the custom text will then show up and ready to be edited.
Turning the global content back on will be the same process, go to the toggle and toggle it back on, save and refresh!
United States HQ 2790 Mosside Blvd. United States (U.S.) |
Europe HQ 3rd Floor, 1 Ashley Road Altrincham, Cheshire, |
©2025 RQM+ All Rights Reserved | Privacy Policy | Cookies Policy