November 29, 2018 | Posted in GRC and Strategy by Mike Pinch   This blog post contains a copy of the questions and comments we’ve submitted to the FDA regarding their latest Medical Device Cyber Security Pre-Market Guidance draft (Link Here).  In our previous blog post, we provided an overview of the draft.  We believe […]

November 8, 2018 | Posted in GRC and Strategy by Mike Pinch   The FDA released draft guidance for cyber security of medical devices on October 18th, 2018, that if instituted, is going to be an enormous change for the industry, including both medical device manufacturers and healthcare providers.  The guidance is aimed at medical […]