#medical devices

The Commercialization of Medical Devices in Europe and the USA: Similarities and Differences
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The American Market Among the motivations that could drive a medical device manufacturer to commercialize...
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Urgent Need to Revise the Medical Devices Regulation
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The resolution on the urgent need to revise the Medical Devices Regulation, presented by several...
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Chemsafe’s Summer Reading Recommendations
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 With the warmth of the summer sun shining down, there is no better time to...
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Clinical Evaluation of Orphan Medical Devices
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What is a Orphan Medical Device? Orphan devices (ODs) are medical devices or their accessories,...
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Microplastic Ban: Impact on Medical Devices and Cosmetic Products
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Starting from 17 October 2023, the EU will enforce a new regulation (COMMISSION REGULATION (EU)...
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March Regulatory Updates
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Biocides: BPC Updates During its February meeting, the Biocidal Products Committee (BPC) of the European...
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November Regulatory Updates
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PVC additives and microparticle releases: The European Chemicals Agency (ECHA) has conducted a thorough investigation...
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Prorogation for submission and authorisations of DEHP application for MD and IVD
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Where we stand with MDR and IVDR European regulations about Medical Devices (Reg. EU 2017/745)...
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Latest Updates on Medical Devices
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Le novità introdotte nella 12a revisione delle SCCS Notes of guidance for the testing of cosmetic ingredients and their safety evaluation
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Il Comitato Scientifico per Sicurezza dei Consumatori (SCCS) è incaricato di valutare la sicurezza e...
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