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Ongoing Study supporting the monitoring of the availability of medical devices on the EU market

What the new Variations Regulation (2024/1701) means

Complex and Time-Consuming Regulatory Operations

Celebrating World Quality Day 2025

Practical strategies for regulatory and clinical success in the EU

Starodub Is heading to Medica in Dusseldorf 

Get ready for serious incident reporting under the AI Act

Starodub & Greijmans Regulatory Consultancy B.V. announce a new strategic regulatory partnership

Distribution of Medical Device Software via app stores

“Medical” in medical devices: the often-forgotten element

Don’t let GSPR be the weakest link in your MDR submission

Quality, Operations & Improvement services

EU eCTD Update – Implementation of Module 1 v3.1.1 & Validation Criteria v8.2

EU-Japan Biotech Mission & BioJapan 2025

Selection of non-clinical models for ATMP development

BioEurope Vienna 3 – 5 November 2025

Have you explored our white paper on the nIVD MA ToC yet?

Understanding new post-market surveillance requirements for medical devices

Seamus Moore
Senior RA Manager
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