Compliance

OUR EXPERTISE

Our experts in the quality, regulatory affairs and compliance fields support the largest healthcare stakeholders in their compliance with legislative, regulatory and administrative requirements.

Our Activities

  • Audit
  • Support
  • Writing
  • Documentation
  • Submission & Declaration
  • Operational support
  • Training
  • Outsourced functions

Our areas of expertise

  • Quality Management System (QMS)
  • Product quality
  • Documents writing, variations, product information...
  • Regulatory & product watch
  • Personal data protection (GDPR)
  • Anti benefits (DMOS)
  • Transparency
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News

The European Union In Vitro Diagnostic Medical Devices Regulation (IVDR)

Universal Medica Group acquires Zebra Santé

How to qualify for orphan designation in the European Union?

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