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New ISO 10993-17:2023 available defining the toxicological risk assessment of medical device constituents
New ISO 10993-17:2023 available defining the toxicological risk assessment of medical device constituents...
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US-FDA publishes a revised guidance “Use of International Standard ISO 10993-1”
On September 8, the FDA published an update of the document “Use of...
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Team NB publishes position paper on transfer agreement for surveillance of legacy devices
On 14 August, Team-NB published the position paper on transfer agreement for surveillance...
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EU Commission Issues an Addendum to MDCG 2022-18 Position Paper on Application of Article 97
Team NB publishes position paper on transfer agreement for surveillance of legacy devices...
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Implementing Regulation (EU) 2023/1194 on transitional provisions for Annex XVI products adopted
In June 2023, EC adopted the Implementing Regulation (EU) 2023/1194 on transitional provisions...
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