Regulatory Strategy for New Neurological Medical Devices
Considerations for an effective balance between non-clinical and pre-clinical evaluations
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.
With extensive experience supporting medical device manufacturers in the field of neurology, our teams have been observing two important trends: the development of novel technologies targeting an existing clinical application and the adaptation of existing technologies to a new clinical application.
In this recorded webinar, Dr Olivier Chevènement and Dr Richard Curno from Veranex discuss:
- 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 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.
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