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International Side Effects Week: How you can (sometimes) prevent side effects yourself
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Comprehensive MDR Compliance: Key Recommendations for Medical Device Manufacturers
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Is Your Post-Market Surveillance (PMS) System Fully MDR-Compliant? 
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Regulatory Affairs, Drug Development & AI: Navigating the New EMA Guidance
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Change in distribution Direct Healthcare Professional Communication in the Netherlands
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Key Outcomes of LSH Dutch Mission to Japan: New Partnerships to Support Market Entry
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Article 61(10) of MDR: A Pathway for Medical Device Software?
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The Compliance Compass: Guiding Clinical Investigations for Medical Devices through ISO 14155 and MDR
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Dutch Life Sciences & Health Mission to Japan
  • Updates

We Are Excited to Attend BioTechX 2024 in Basel!
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EMA Pilot Program for Orphan Medical Devices
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Biological Evaluation of Medical Devices from a Risk Management Perspective: Key Steps and Common Pitfalls
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Vigilance and Incident Reporting of Medical Devices per MDR 2017/745 
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Starodub’s eCTD team present at eCTD v4.0 Masterclasses
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Product for Diagnostic Purposes: Medical Device or Medicinal Product
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Impact of the new EU Artificial Intelligence Act on medical devices
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New revision of Guideline on Environmental Risk Assessments by EMA
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Windsor Framework – Changes to the licensing of medicines for human use in the UK (and affecting Northern Ireland)
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Leon Vaes
Senior RA Consultant
Leon Vaes

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