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Due Diligence

The newspapers are filled with mishandled mergers. Selecting the right company in which to invest in or acquire is a risky decision. You must rapidly and cost effectively evaluate new medical device ideas and the management running the companies. The medical industry presents an additional set of unique challenges. Assessing the viability of a medical device manufacturer requires regulatory and compliance experience and a specific skill set to make informed investment decisions. Not understanding the target company’s regulatory standing may mean long delays to market, recalls, or fines, that damage the value of the investment.

At MEDIcept, we have the expertise and experience to help investors make the right decision and maximize return on investment. We understand regulatory and clinical strategies, and what it takes to get a medical product to market – we work with these companies everyday. We have assessed investments for companies with a combined value of over $800 million.

Our due diligence assessment and analysis program can include:

  • National and international regulatory strategy
  • Product classification
  • GLP/QSR/GMP compliance
  • Marketing compliance
  • Product labeling compliance
  • Clinical evaluation reports

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The Latest News

FDA Updates Special 510(k) Guidance

FDA’s Special 510(k) submission process has been around for years as an expedited method to demonstrate that the device to be marketed is at least as safe and effective (i.e., substantially equivalent), to a legally-marketed device not subject to the Premarket Approval (PMA) process. In September 2019, a modified version of this program was published to create a streamlined review of technological changes made to a manufacturer’s own cleared device which leveraged design control requirements....

Metal Implants: FDA’s November, 2019 Immunology Devices Panel Meeting

The Immunology Devices Panel of the FDA’s Medical Device Advisory Committee met in November to discuss the topic of immunological responses to metal-containing products regulated as medical devices. The panel focused on metal-containing implants as well as dental amalgam. Recent post-market issues with some metal-on-metal orthopedic implants and gynecological metal-containing implants have raised questions about the potential for some patients to develop unexpected or heightened biological...

Quality Systems in Motion, Inc. (QSIM) is now part of MEDIcept Inc.

For Immediate Release Ashland, MA: MEDIcept Inc, an international quality, regulatory, and clinical consulting firm focused on medical device and in-vitro diagnostics (IVD), and QSIM, a US-based privately held consulting firm specializing in medical device/biotechnology, announces the merger of the two companies. QSIM, under the direction of Brian Markham, President, specialized in providing leadership and resources for organizations undergoing significant quality system change due to...