A common misconception in the Medical Device industry is that FDA is impossible to interact with and that they have no interest in working with […]
TAP to Break the Stigma of FDA’s Inaccessibility Read More »
FDA’s Proposed Guidance on Conducting Remote Regulatory Assessments Remote. Remote. Remote. Since the COVID-19 pandemic started in 2020, this is the word we now use
FDA Remote Regulatory Assessments Are Here To Stay Read More »
As artificial intelligence (AI) and machine learning (ML) become more popular in the healthcare and medical device industry, their use could irrevocably change the way
10 Regulatory Commandments of Artificial Intelligence Read More »
Cyber security may be expensive, but the cost of a life is more By: Giselle C. Matlis, Research Assistant Imagine someone hacks your Facebook account.
The Need for Cyber Security in the Healthcare System Read More »
By: Giselle C. Matlis, Research Assistant On August 29, 2017 the FDA published a Safety Communication, Firmware Update to Address Cybersecurity Vulnerabilities Identified in Abbott’s
FDA confirms: Hacking a pacemaker only requires commercially available equipment Read More »
By: Giselle C. Matlis, Research Assistant On Monday June 26th 2017, Medtronic announced that they will be using a “new outcomes-based [payment] agreement with Aetna
#newidea or #throwbackthursday? Read More »
