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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

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...

Medical Device Risk Management: An ISO14971 Update

In 2000, the first edition of ISO 14971 was released as the international standard for risk management of medical devices. This year, the ISO technical committee (ISO/TC 210) has been hard at work updating this globally-recognized standard. And while the fundamental stages of the risk management process remain unchanged, there are some key modifications that medical device manufacturers should be aware of to ensure that they can successfully navigate the development, testing, and launching of...

Europe’s New Medical Devices Regulation: Ready or Not, Here It Comes

For the past 30 years, the European Union’s medical device market has been regulated by the Medical Devices Directive (MDD). The rapid development of hybrid technologies, tensions between EU member states, and highly bureaucratic procedures for resolving disputes made the text of the Medical Devices Directives seem obsolete much earlier than anticipated. As a result, the European Commission authorized the development of a new set of industry requirements known as the Medical Devices Regulation...