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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

Windsor Framework – Changes to the licensing of medicines for human use in the UK (and affecting Northern Ireland)

Leon Vaes
Senior RA Consultant
Leon Vaes

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