Regulatory Compliance Services for Medical Devices

Key Details

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,