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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

Mobile Medical Apps

In today’s wireless world, it seems everyone has a smartphone and it’s revolutionizing how services and information are presented and accessed. In the healthcare industry, this means rapid advances in telemedicine and the development of mobile medical apps (MMAs) which raise some unique concerns for compliance and challenges for regulation by the FDA and medical regulatory submissions. It is important to determine if your product is a regulated MMA or not a medical device. On May 17, 2019, the...
MEDIcept

Digital Health Innovation and Regulatory Compliance

Advances in digital health technology and innovation are picking up speed as wireless communications continue to evolve and become incorporated in growing numbers of devices, systems, and networks. The cloud, , are only fueling the demand for wireless and cloud-based integration of medical devices, which promises to improve the delivery of healthcare, often at reduced costs. Telemedicine, wearable devices, artificial intelligence (AI), and remote diagnostic and monitoring systems are just some...

Two Premier Medical Device Firms Merge to Provide More Comprehensive Services

Ashland, MA: MEDIcept Inc, a leading international quality and regulatory consulting firm focused on medical device and in-vitro diagnostics (IVD), and Reilly & Associates, a US-based privately held consulting firm specializing in medical device/biotechnology, announces the merger of the two companies.The merger promotes the shared strategic goal of becoming a world-wide, leading quality and regulatory value-added service firm focusing on medical devices and medical technology....