Most trusted source for Tendering Opportunities and Business Intelligence since 2002
Most trusted source for Tendering Opportunities and Business Intelligence since 2002
Country - United Kingdom
Summary - Medical Device Regulatory Compliance
Deadline - Oct 24, 2024
GT reference number - 95252565
Product classification - Repair and maintenance services of medical and surgical equipment
Address - United Kingdom
Contact details - 565656565
Tender notice no. - 76454545
GT Ref Id - 95252565
Document Type - Tender Notices
Description - Description: There are currently 5 Software medical devices (SaMD) products registered with the MHRA with NHSE as the legal manufacturer. These products are classified as the lowest risk class-Class 1 devices under the current Medical device regulati on (UK MDR 2002). However, the regulation is currently being revised and the amended regulation will be published in July 2025 by the MHRA. The new updated regulation is expected to be stricter with tougher compliance requirements on the legal manufacture.We therefore need to update NHSE software medical device products' testing, validation and technical documentation to bring the products in line with the expected requirements of the amended reg
Gt Ref Id - 95252565
Deadline - Oct 24, 2024
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