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Oct, 28 2019

MEDICAL DEVICES – EUROPEAN REGULATION 20...

26 May 2020, the date of entry into force of Regulation (EU) 2017/475 on Medical Devices (the MDR), it is getting closer, yet at t...

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Oct, 28 2019

MEDICAL DEVICES – EUROPEAN REGULATION 20...

One of the main changes that will most affect the Medical Device regulatory field is included in Annex VIII of the new Regulation ...

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Oct, 22 2019

REGULATORY AFFAIRS – NITROSAMINES: W...

In June 2018, N-nitrosodimethylamine (NDMA) and similar compounds known as nitrosamines, classified as probable human carcinogen b...

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RPN @regulatorypharmanet - JUN 4

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