by ptlsolut | Dec 6, 2023 | Q&A
Today, we interview Haley Schwartz, one of our experts and most respected voices, to discuss strategies and tips for medtech start-ups, regardless of size, to achieve success in both the US and global markets. Haley is a passionate commercialization expert with over...
by ptlsolut | Nov 14, 2023 | FDA Compliance, Medical Device Cybersecurity
As of Oct 1, lax cybersecurity is grounds for FDA rejection and potential criminal prosecution For years, the FDA has coaxed medical device makers to take cybersecurity seriously. A law ensuring cybersecurity for medical devices passed by Congress in Dec ‘22, had a...
by ptlsolut | Oct 31, 2023 | FDA Programs
Is STeP right for your medical device? In 2021, due to the success of the Breakthrough Technologies program, the FDA created a new program called the Safer Technologies Program (STeP) to bring medical devices to market faster for conditions that are less serious than...
by ptlsolut | Oct 23, 2023 | FDA Programs, Regulatory Strategy
How to leverage the FDA’s newest pilot program for speed to market and post-approval market success Just announced: the FDA will continue to grow its pilot TAP (Total Product Life Cycle Advisory Program), which currently has 15 devices accepted. Starting October 1st,...
