Use Specification Template

A use specification is required to demonstrate that the usability engineering process, as required by IEC 62366-1:2015 + AMD:2020, has been followed and to provide evidence that acceptable risk related to the usability of the medical device is ensured.

The use specification is the foundation for all further usability engineering activities and their documentation.

This valuable template will provide you with a framework to complete the use specification.

It may also be used as a benchmark on your existing use specification. The template includes topics required by clause 5.1 of IEC 62366-1:2015 + AMD:2020.

This valuable template, originally priced at $109, is being offered to you for free by Medical Device HQ, the developer of the tool and a trusted partner of Greenlight Guru.

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About Medical Device HQ

At Medical Device HQ, we specialise in delivering high-quality training solutions for professionals in the medical device industry. Trusted by individuals, companies, and regulatory bodies, we are dedicated to delivering excellence in every aspect of our training programs.

One thing that sets us apart is that our courses are created by members of the standardisation committees that authorise the ISO and IEC standards.

Annually, we serve more than 3000 professionals globally, providing them with the knowledge and skills necessary to progress in their careers.

Contact us today to discover how Medical Device HQ can help you achieve your professional goals and navigate the complexities of medical device product development with confidence.


About Greenlight Guru

Greenlight Guru provides the leading cloud-based solutions for MedTech companies to bring life-changing products to people faster, and with less risk.

Greenlight Guru provides purpose-built quality management, product development, and clinical data management solutions that together help teams accelerate timelines, streamline compliance, and deliver high-quality products.

With Greenlight Guru, companies across the globe are improving efficiency, speed, and quality in every aspect of their organization to get products to market faster and keep them on the market longer.

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