Class Definition of your Medical Device.
Establish a Quality Management System.
Risk Management Plan for CE Marking and/or FDA clearance.
Clinical Evaluation. How to design, when to apply and more.
Build your Strategic Roadmap for evidence demonstration and Registration Dossier filing.
Access to Market to identify and estimate the target populations, as well as the price potential.
CE mark vs FDA requirements, setting one foot on each side of the Atlantic NGHD’s DNA.
Digital Medical Device conception (62304 implementation)
Establishing a software under the Medical Device status is a challenge, different standards apply, development under the “agile” form is possible under certain conditions.
IVD (In Vitro Diagnostic) Option
Implementation IVDR 2017/746/EU
The development of an IVD follows a specific regulation which evolves with the new adjustment.
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