Clinical strategy, evidence and evaluation are central to product approval and market access. It’s a requirement of the new EU Medical Device Regulation (MDR: article 61) that a medical device company have a regulatory strategy and of the MDR and MEDDEV 2.7/1 rev 4 that the company have a clinical evaluation strategy.
In order to generate sales, organisations need to have thought through the clinical elements for market access as this will put them back months, if not years, if not understood and completed when initially gathering clinical evidence.
Companies need to be prepared and have solutions in place to address this and their ongoing clinical requirements. Getting your clinical strategy wrong will delay approval and also access.
- Understand clinical strategy and how that fits within an overall company strategy
- Understand the role of clinical investigations, evaluations, evidence and post market clinical follow ups
- Understand how clinical evidence and the role of clinical strategy enables market access
- Interact with fellow practitioners and presenters during the Q&A