In the simplest of terms, the FDA’s Q-Submission (Q-Sub) program is a voluntary...
What is the FDA Q-Submission program?
In the simplest of terms, the FDA’s Q-Submission (Q-Sub) program is a voluntary process in which sponsors or submitters can engage and request formal feedback from the FDA. This feedback is in response to specific questions raised by the submitter, often related to product development and/or preparation of a premarket application.
Understanding the Japanese medical device approval process
Home to several medical device companies, the Japanese market is one of the largest in the world. But despite the country’s own advances in technology and pharmaceuticals, many of the medical devices marketed in Japan are manufactured by foreign firms. In fact, Japan is amongst the most lucrative of markets for international manufacturers.
Brian Ludovico Q&A: NSF executive director on the benefits of joining MDSAP
The Medical Device Single Audit Program (MDSAP) was introduced in 2014 for a three-year pilot program to allow a single audit that ensures the regulatory requirements for participating countries are satisfied.
Medical device consultancy services: Interview with NSF’s James Pink
NSF’s Medical Devices executive vice president James Pink has the experience and the know-how to guide manufacturers through even the most complex regulatory quandaries. With over two decades experience in the medical devices industry, including ten years as a healthcare technology expert and lead auditor for a leading European notified body, he understands the big issues facing the medical device industry.
Q&A | EU MDR: What does it mean for the medical device industry?
The new EU MDR raises a lot of uncertainty and concerns for manufacturers. Kim Trautman, NSF International executive vice-president, talks about the challenges for the industry and how these can be addressed.
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