Health Innovation Euregion 2025

12 Jun 2025 | Netherlands

ServiceUpdated on 4 June 2025

The correct product risk classification is key to know your regulatory obligations

Monique Greijmans

Regulatory & Quality Expert at Greijmans Regulatory Consultancy B.V.

Region South-East, Netherlands

About

Service to determine product risk classification and regulatory obligations:

  1. Leading the assessment based on intended purpose, use cases, context of use, claims  and risks.

  2. Clarifying applicable requirements & obligations for compliance and governance.

  3. Providing full justification, captured as part of the decision tree for future submission.

Regions / legislation:

  • EU MDR & EU IVDR

  • EU AI Act

  • FDA

Type

  • Innovation management
  • Consulting
  • Research & Development

Applies to

  • Life Science

Organisation

Greijmans Regulatory Consultancy B.V.

Company

Region South-East, Netherlands

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