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Medical Devices with Coatings: Impact on Classification

From Formatting to Submission: End-to-End eCTD Support

AI in Medical Devices: Key Highlights of the New Team NB Position Paper

Public consultations on package insert and labelling policy

Starodub is attending Medica 2024

Exciting News from Starodub!

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

Iryna Berchak
RA Consultant
Iryna Berchak

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