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  1. What is the FDA Q-Submission program?
  2. Understanding the Japanese medical device approval process
  3. Brian Ludovico Q&A: NSF executive director on the benefits of joining MDSAP
  4. Science at the cutting edge: Why Britain is great for digital health and medical technology businesses

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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.

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.

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