medical device repair

Clarity will help stem the problem of ‘winners and losers’ in medical device safety and security

The Clarifying Remanufacturing to Protect Patient Safety Act was introduced by Reps. Scott Peters (D-CA), Kim Schrier (D-WA), and John Joyce (R- PA) to clarify the meaning of medical device remanufacturing and empower the FDA to educate company technicians so they know if they’ve crossed the line into a regulated activity.

By Julianne Malveaux

MedCity Influencers, Opinion

Congress must regulate medical device repair to protect patients

By increasing oversight and regulation of independent service operators to ensure the quality, safety, and effectiveness of all device servicing Congress and the FDA can prevent future patients and providers from having to experience unnecessary harm caused by faulty medical device repair.

By Julianne Malveaux

With the Rise of AI, What IP Disputes in Healthcare Are Likely to Emerge?

Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.