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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 Whitepapers

Approaches to include drug substance quality information in a drug product application (June 2022)

How to select a cell line to produce a biosimilar (June 2021)

Combination products in the EU MDR (May 2021)

News on the Postponement of the EU Medical Device Regulation, Corrigenda and MDCG guidance (June 2020)

EU MDR impact on importers and distributors (March 2020)

Biopharmaceutical products – Do you have your reference standard program in place? (December 2019)

Radiopharmaceuticals – How to Register in EU? (October 2019)

Is your Active Pharmaceutical Ingredient quality control strategy up to standard? (July 2019)

What is new under the EU MDR for software manufacturers? (December 2018)

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