ServiceUpdated on 27 January 2025
Product Classification and Categorization
About
> Determine main Mode of Action and product categorization (MD, IVD, Combination product, Drug, etc.)
> Classify the device according to the EU MDR and IVDR and/or the US FDA guidelines
> Review similar devices in the EU/US markets
> Provide recommendations on product claims and intended use
Type
- Consulting
Organisation
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Service
- Coaching
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Tabatha Bourgois
Director, Regulatory and Clinical Development at Alira Health
Barcelona, Spain
Service
- Medtech
- Consulting
- Biotech and Lifescience
Tabatha Bourgois
Director, Regulatory and Clinical Development at Alira Health
Barcelona, Spain
Service
Csaba Sántics
Consultant, Instructor, Auditor at SAASCO Kft.
Budapest, Hungary