ServiceUpdated on 4 June 2025
The correct product risk classification is key to know your regulatory obligations
Regulatory & Quality Expert at Greijmans Regulatory Consultancy B.V.
Region South-East, Netherlands
About
Service to determine product risk classification and regulatory obligations:
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Leading the assessment based on intended purpose, use cases, context of use, claims and risks.
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Clarifying applicable requirements & obligations for compliance and governance.
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Providing full justification, captured as part of the decision tree for future submission.
Regions / legislation:
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EU MDR & EU IVDR
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EU AI Act
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FDA
Type
- Innovation management
- Consulting
- Research & Development
Applies to
- Life Science
Organisation
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Region South-East, Netherlands
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