Guiding you through post-market activities and requirements

Post-market activities are not just mandatory requirements, but crucial throughout the product lifecycle in MD and medtech. With our expertise in facilitating communication and streamlining processes, we aim to help you meet all FDA regulations.

With years of experience, we offer comprehensive support in the following areas:

  • Country registration (including renewal)
  • Assessing and implementing design changes
  • Assessing feedback from the market, complaints, and incidents (non-serious and serious), including vigilance (and/or FSCA) reporting support
  • Clinical evaluation updates
  • Post-market surveillance reporting update
  • Post-market clinical follow-up

Experience and expertise in post-market support

  • Our know-how ensures efficient management of post-market information inputs.
  • We are skilled in assessing marketing feedback, including complaints trend reporting.
  • Our dedicated team of experts in the clinical domain ensures that post-market activities align with clinical best practices and regulatory standards.
We provide complete and efficient service to our clients. We can support you at any stage, helping you solve complex problems, and continue to support you in after-marketing authorization approval. Our drive is to help our clients, with always the patient in mind.

Alex Zwiers

Product Development Business Executive

Alex Zwiers – Post-Market Support in Medtech and IVD