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EU MDR Regulations

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Regulation (EU) 2017/745 is a regulation of the European Union on the clinical investigation and sale…
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Artificial Intelligence Based Regulat…

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VISTAAR provides Global regulatory submission requirements, guidance documents, updates, news and oth…
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Medical Devices–USA/Europe Regulatory…

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EUROPE MDCG 2022-16 – Guidance on Authorised Representatives Regulation (EU) 2017/745 and Regulati…
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Medical Devices – Asia Regulatory Upd…

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INDIA (CDSCO) Extension of last date for filing statutory forms prescribed under DPCO, 2013-reg …
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Medical Device – Regulatory &am…

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The Medical Device industry is one of the largest industries in the healthcare sector, with significa…
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MHRA Guidance for Medical Device Manu…

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Adverse incidents involving medical devices that occur in the UK must be reported to the Medicines an…
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