Whitepaper - The impact of regulatory requirements on bringing medical devices to market.
There are many steps involved in the process of bringing a device to market, especially examining the regulatory environment in which medical device customers operate. Depending on your device, its indications or the presence of drug or biologic components, submissions to the U.S. FDA, EU Notified Bodies or Competent Authorities, and other regulatory bodies might be considered, but if you're using a component as a layer between other components of your medical device, or if you're using a component to adhere a device to skin, more may be expected from you by the FDA or other regulatory agency reviewers. When adhering a device to skin special attention should be given to the final, finished device composition and biocompatibility, inclusive of all component(s).
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