Aligning clinical evidence and market access for you medical device

January 31, 2024

Join us on the 21st of March in Lund, when Key2Compliance will host the Medtech Network, organized by Medicon Valley Allicance.

The manufacturer´s focus during the medical device life-cycle is to continuously ensure safety and performance of the device, this is done by iterating/updating the technical documents such as the clinical evaluation and risk management regularly and when triggered.

Collecting clinical data by investigations is time consuming and costly. Market access is not only dependent on regulatory compliance but in addition expectations and requirements from a health economic perspective is generally needed.

Understanding the need for such expectations early on in the process of collecting your clinical data is imperative. During the event ways to include not only a regulatory strategy but also a clinical strategy will be discussed. Challenges, solutions, and lessons learned both from European and US market will be shared. Success stories and facilitating tips for how to handle regulatory compliance, the clinical evaluation and post- market surveillance/ PMCFs is on the agenda.

The aim of this meeting is to provide the basis for knowledge sharing and a fruitful dialogue on how you may align clinical data collection and market access for your medical device.

Join us on March 21st in Lund for insights on aligning clinical evidence and market access for your medical device. Register now!