Medical device quality and regulatory consultant MEDIcept has launched a new, online resource for medical device manufacturers to get help with testing and quality issues as well as regulatory compliance and submission challenges.
According to MEDIcept president David Rothkopf, the new website enables medical device manufacturers to seek assistance for a wide range of issues to avoid costly delays in launching new medical products. “Medical device manufacturing is one of the most heavily regulated industries in the world. Recently the FDA has been scrutinizing submissions even more closely – it’s not uncommon to see a submission with more than twenty comments, delaying the release of a product and causing a company to lose revenue and market share, “states Rothkopf. “ Even the most minor mistakes in medical product design, validation, or submittal can be costly at best, delaying time to market and at worst failing to get a product to the market at all. This new website enables medical device manufacturers to seek help for navigating the complex international regulatory environment.”
Medical product manufacturers visiting the new website will find free informational white papers and helpful links to information on regulatory strategies and submissions, quality assurance system development, FDA and ISO 13485 compliance, as well as corrective and preventative action program development to protect products after they’re introduced to the marketplace.
MEDIcept (medicept.com) is a vertically integrated medical device quality assurance, regulatory consulting and contract testing firm owned and managed by medical industry professionals with direct experience managing medical device development, operations, quality, and regulatory activities.