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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 Inspection? We Can Help You Relax.

Nothing can strike fear into the heart of a medical device manufacturer quite like an unexpected notice from the FDA. How you prepare for an FDA inspection? What is the process? What are they going to look for? Are they really that mean? After the inspection how do you respond to a 483 notice or worse what happens if you received a warning letter? How you perform during the inspection can make all the difference in the world between a quick resolution and a long expensive remediation program....
MEDIcept

Validating Medical Devices

One of the cornerstones of medical device manufacturing is the ability to efficiently and cost-effectively validate medical devices to ensure FDA compliance and to successfully and profitably bring medical products to market. Proper validation is a core requirement for any medical device manufacturer looking to achieve regulatory agency compliance and sell their products domestically and internationally. At MEDIcept, we understand that medical device testing is a rigorous and complex process...

We are state-of-the-art in the validation process

US Food and Drug Administration (FDA) and international regulatory standards continue to evolve and become more stringent as medical devices become more complex in design, functionality, and technological integration. This makes the process of medical device validation and verification even more important—not only to comply with regulations, but also to aid in the design of the highest-quality components and the production process. The desired result is better repeatability, fewer mistakes,...