Regulatory Due Diligence for (IVD) Medical Devices

Handshake in a Business Context

Our comprehensive regulatory evaluation provides you with a clear basis for making investment decisions

Ensure Faster Market Launch

Avoid costly delays by identifying and over­coming regulatory hurdles at an early stage. Our evaluation is available in only two to four weeks.

Minimize Investment Risks

Make your purchase decision based on trans­parent facts. Our traffic light rating shows you precisely where you stand and what costs you can expect.

Secure Global Marketing

Make sure you can sell your medical and IVD medical devices in all target markets. We check the requirements of all relevant markets in one go.

Save Time and Resources

Benefit from our comprehensive expertise instead of coordinating multiple service providers – one point of contact, all expertise from a single source.

Team Analyzing Documents in the Office

Our regulatory due diligence service enables you to make informed purchasing deci­sions in only two to four weeks

As an investor or buyer, you must make impor­tant decisions. You want to acquire a medical device company or its devices, but you:

  • lack the regulatory expertise to assess the devices and their documen­tation.
  • fear that you will incur large unplanned costs to close regulatory gaps.
  • don't want to buy a “pig in a poke” and be surprised by regulatory issues later.
  • are concerned that potential regula­tory issues could delay or prevent the sale of the devices in existing or future markets. 
Man and Woman Looking Through a Document

Our due diligence offer: a comprehensive inspection and a precise evaluation by our experts

We analyze all relevant regulatory aspects of the devices and documen­tation for your target markets. You then receive a clearly structured evaluation with:

  • a clear traffic light assessment of the most important aspects
  • a detailed list of regulatory non-conformities
  • specific time and cost estimates for necessary adjustments
  • clear recommendations for action

Contact us now to discuss your due diligence requirements in a first meeting. 

 

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