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International Side Effects Week: How you can (sometimes) prevent side effects yourself

Comprehensive MDR Compliance: Key Recommendations for Medical Device Manufacturers

Is Your Post-Market Surveillance (PMS) System Fully MDR-Compliant? 

Regulatory Affairs, Drug Development & AI: Navigating the New EMA Guidance

Change in distribution Direct Healthcare Professional Communication in the Netherlands

Key Outcomes of LSH Dutch Mission to Japan: New Partnerships to Support Market Entry

Article 61(10) of MDR: A Pathway for Medical Device Software?

The Compliance Compass: Guiding Clinical Investigations for Medical Devices through ISO 14155 and MDR

Dutch Life Sciences & Health Mission to Japan

We Are Excited to Attend BioTechX 2024 in Basel!

EMA Pilot Program for Orphan Medical Devices

Biological Evaluation of Medical Devices from a Risk Management Perspective: Key Steps and Common Pitfalls

Vigilance and Incident Reporting of Medical Devices per MDR 2017/745 

Starodub’s eCTD team present at eCTD v4.0 Masterclasses

Product for Diagnostic Purposes: Medical Device or Medicinal Product

Impact of the new EU Artificial Intelligence Act on medical devices

New revision of Guideline on Environmental Risk Assessments by EMA

Valentyna Starodub
Founder and Chief Executive Officer
Valentyna Starodub

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