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One standardized icon set for clearer medication information
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EMA Updates Post-Approval Application Guidance Effective 1 January 2025
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Updates on eCTD Submissions for the EU: Are You Ready?
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How ready are you for MDR submission?
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Regulatory Affairs: A Marathon of Dedication and Strategy
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Looking Back on Milestones and Forward to the Future
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Interpretation of Well-Established Technology (WET) under the EU MDR
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Medical Devices with Coatings: Impact on Classification
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From Formatting to Submission: End-to-End eCTD Support
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AI in Medical Devices: Key Highlights of the New Team NB Position Paper
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Public consultations on package insert and labelling policy
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Starodub is attending Medica 2024
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Exciting News from Starodub!
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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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Leon Vaes
Senior RA Consultant
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