With the entry into force of the European Artificial Intelligence Act (AI Act), manufacturers of AI-based software in the healthcare sector must ensure that their Quality Management System (QMS) complies with additional requirements beyond those already established under ISO 13485 and the MDR.
At Asphalion, we help our clients evolve their existing QMS without the need to start from scratch, by identifying the AI Act–specific gaps (data governance, AI risk management, post-market monitoring, additional documentation, etc.) and creating or updating the procedures and records required to ensure regulatory compliance.
Our service includes:
- Gap analysis between ISO 13485 and the AI Act.
- Definition and update of SOPs and processes to cover AI requirements.
- Implementation of AI-specific controls and documentation (data management, robustness, transparency, cybersecurity).
- Seamless integration into the existing QMS, avoiding duplications.
With this approach, manufacturers can anticipate regulatory demands and ensure the safety, transparency, and traceability of their AI solutions in Europe.
Be AI Act-ready with Asphalion as your trusted partner!
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