Regulatory and Market Access services

To help you accelerate market access, genae offers a range of regulatory support services. Whether your clinical trial takes place in the EU or the US, our experts assist you on your market access.

Regulatory Consulting (EU)

genae advises medical device developers on a broad range of regulatory aspects 
including matters such as (borderline) device classification, route to conformity, 
risk management or on the design of a clinical strategy. Our regulatory team 
furthermore has experience to support you with your clinical evaluation. Our 
experts can assist you with designing a new Clinical Evaluation Report (CER) or 
updating an existing one and are fully equipped to conduct a gap analysis between 
your CERs and the most current European requirements.

Benefit-Risk Assessment (FDA)

In the US, the testing of a device's safety, effectiveness, and quality is regulated by stringent regulations of the FDA. genae has profound knowledge of these regulations and can provide insight on risk mitigation and clinical benefits of investigational devices.

Penny Sekerak

genae has been outstanding to work with. We very much appreciated their team remaining on top of project changes and constantly going the extra mile.

— Penny Sekerak, VP Professional Education & Clinical Affairs
​​​​​​​NICO Corporation, USA

Market Access and Reimbursement Strategy

Let genae set up the optimal strategy to access your device market. Qualifying your medical device for reimbursement can be a long process, we will help you to:

  • define the reimbursement class
  • set up a strategy to obtain the highest level of reimbursement
  • define the steps needed to navigate you through the process

genae can help you to enter new markets quickly and cost-effectively.

Medical Device Vigilance

Does your company have the required resources to perform the new stringent surveillance requirement on medical devices? genae can help you by supporting incident handling, including clinical assessment and reporting to authorities. You can rely on our understanding of requirements and our international presence.


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