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Medical device approval (FDA) with a focus on cybersecurity
The customer wants to obtain FDA approval for a medical device used in operating theatres (eSTAR programme). To do so, they need support in the area of cybersecurity.
EXCO Services
- Advice on FDA approval of a medical device for use in operating theatres as part of the eSTAR programme
- Cybersecurity consulting in the context of licensing
- Assessment of the security and architecture views required for approval
- Support in the preparation and revision of the relevant documents
Client benefits
- Support with implementing the eSTAR programme requirements
- Improved customer understanding of the requirements for the various views
Client
Medical technology company