[WEBINAR] Regulatory Strategy for New Neurological Medical Devices

November 21, 2023
|In Regulatory Affairs
|By Marieke Moliner

Regulatory Strategy for New Neurological Medical Devices

 

Regulatory considerations and preclinical aspects are major parts of getting any medical device to market. Finding an efficient and cost-effective strategy is particularly challenging when the device in question:

  • has a high degree of invasiveness;
  • has novel features or requires a novel surgical procedure;
  • is complex and expensive to produce, such as in the case of active implantable medical devices or implantation devices within the field of neurology.

    •  

    In this recorded webinar, Dr. Olivier Chevènement and Dr. Richard Curno from Veranex provide you with:

  • The most common regulatory challenges faced by medical device companies
  • A typical approach to developing a regulatory strategy, which includes the design and planning of V&V and pre-clinical evaluations in support of the conduct and planning of a First in Human investigation
  • Common strategies and considerations, with example case studies, to find an economical and efficient balance between non-clinical and preclinical evaluations
  • Common synergies between different aspects of non-clinical evaluations, including test device selection and use of dummies, as well as pre-clinical study design and considerations that can be supportive of the regulatory strategy.

    •  

    WATCH THE WEBINAR

    Please submit the form to watch: