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Ben Kemp

MedTech Europe Updates Regulatory Affairs NewsletterMedTech Europe Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

Manufacturer’s Declaration in relation to Regulation (EU) 2024/1860

Dear Members, MedTech Europe have drafted a manufacturers declaration to Regulation (EU) 2024/1860, the latest IVD regulation transitional legislation. The declaration can be used to support the continued use of IVD Directive Certificates that have expired, but where the manufacturer continues to meet the requirements of the updated legislation and Article 110 of the IVD Regulation 2017/746. To: Regulatory Affairs…
Ben Kemp
September 11, 2024
Other Updates Regulatory Affairs NewsletterOther Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

BSI AI algorithm auditing and dataset testing

In preparation for incoming AI legislation, BSI has proactively developed an Algorithm Auditing and Dataset Testing service to help organizations prepare for success. An Algorithm Auditing & Dataset Testing confirmation letter from BSI demonstrates to customers, regulators, and other stakeholders that your algorithm performance claims have been verified by an impartial and independent third party. Establish trust and credibility in…
Ben Kemp
September 11, 2024
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