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Aperlena

Regulatory Compliance Services for Medical Devices

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  1. Published
  2. Awarded pending

Summary

Machine-generated summary

NHS England awarded a contract for regulatory compliance services for medical devices. The services support achieving ISO 13485 certification, a critical requirement for developing and deploying higher-risk software and AI medical devices, including the planned Probabilistic AI Triage product. The arrangement ensures continuity of expertise, retains organisational knowledge built over the last two years, and avoids delays to regulatory, quality and medical device activities. The contract was awarded to DevicePharm Consultancy Limited. The services also support the continued maturity of the Quality Management System and provide business continuity.

Description

Support in respect of the achievement of ISO 13485 certification, a critical requirement for the development and deployment of higher-risk software and AI medical devices, including the planned Probabilistic AI Triage product. The service is essential to ensure continuity of expertise, retain critical organisational knowledge built over the last two years, and avoid delays to regulatory, quality and medical device activities. The proposed arrangement will provide business continuity, support the continued maturity of the Quality Management System,

Official source

Source: Find a Tender Service (UK Cabinet Office / Crown Commercial Service)

Always verify details on the official notice.

Last verified against Find a Tender Service (UK Cabinet Office / Crown Commercial Service) 5 hours ago

Documents on Find a Tender Service (UK Cabinet Office / Crown Commercial Service) (English)

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210 notices tracked · 146 awarded
€387,680,345 in awarded contracts

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