The current medical device regulation in the European Union (EU-MDR) includes the term clinical evaluation more than 140 times!
Clearly, clinical evaluation is now more important than ever under EU-MDR (and IVDR). As a result, a general feeling in the medical device industry is that it is now significantly more challenging to bring innovative new devices to market.
Sarah Panten advises practitioners to clearly define clinical benefits of their as part of the clinical evaluation and document the benefit-risk evaluation in the context of the State of the Art. Realize that post-market surveillance is an active process of information collection and review, and that it must be tightly integrated with the clinical evaluation process on a continual basis.
About Sarah Panten
Sarah Panten is currently the Co-Founder and Managing Partner at avasis, which provides digitalization services to companies in the medical device and machinery industry. She has worked as a trainer and a consultant for more than 10 years at different organizations including TUV SUD and NSF. In 2014, she initiated the digitalization of the design control process at iThera Medical to manage complexity and traceability of information. Her current focus is to develop medical device specific software solutions based on the Siemens Polarion software platform to help companies efficiently implement regulatory requirements.
About Let’s Talk Risk! with Dr. Naveen Agarwal
Let’s Talk Risk! with Dr. Naveen Agarwal is a weekly live audio event on LinkedIn, where we talk about risk management related topics in a casual, informal way. Join us at 11:00 am EST every Friday on LinkedIn.
Disclaimer
Information and insights presented in this podcast are for educational purposes only. Views expressed by all speakers are their own and do not reflect those of their respective organizations.
LTR 24: Clinical evaluation is a lifecycle process, not a one-time activity