IEC 81001-5-1
IEC 81001-5-1 is a modification of the IEC 62443-4-1 standard, specifically adapted to the medical device sector. It focuses on manufacturers of “medical software,” which includes not only medical devices but also other software used in healthcare. The standard defines lifecycle requirements for the development and maintenance of medical software. Its goal is to ensure safety and protection, while also maintaining a balance between the key characteristics of medical software.
Certification under this standard will be highly beneficial for medical device manufacturers, as it is strongly aligned with the new Medical Device Regulation (MDR).
From Initial Training to Certification:
EZÚ offers comprehensive support for IEC 81001-5-1 compliance:
GAP Analysis – assessment of the current state of processes and documentation against the standard’s requirements
Tailored Training – customized training for employees in IEC 81001-5-1, designed to meet the specific needs of each client
Pre-audit – a detailed preliminary assessment of readiness for certification
Certification – independent verification of compliance with the standard’s requirements
Sales
Ing. Lenka Mariánková
Product Manager
Technical specialist
Jan Henyš
Cyber Security Specialist
Why choose EZÚ?
- Experienced expert auditors.
- Personnel at the very highest level.
Reasons to get certification
- Fulfilment of obligations under legislation for public authorities.