ISO Compliance

Case Study
Medical Startups – IEC62304 Standard Implementation

Project Highlights

Ameliot helped several medical device startups in the UK and the EU to implement the IEC 62304 “Medical Device Software – Software Life Cycle Processes” Standard for medical devices that use sensing technology to monitor patients’ vital life signs. We produced all documentation for certification audits.

IEC 62304 is the international Standard that defines software development lifecycle requirements for medical device software. As software becomes an ever more important component of medical devices, compliance with this Standards has become essential. The IEC62304 Standard must typically be implemented in conjunction with the ISO13485 “Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes” Standard.

 

The numbers

The IEC62304 standard requires all aspects of the software development life cycle to be scrutinised, including:

  • Development
  • Risk management
  • Configuration
  • Problem resolution, and
  • Maintenance

The IEC62304 Standard provides a common framework for medical device manufacturers to develop software. Conformance with this standard provides evidence that there is a software development process in place that fulfils the requirements of the Medical Device Directive.

  • Client Satisfaction – 100%
  • On Time Project Delivery – 100%
  • Position on Route to First Certification – 50%

PROJECT LENGTH IN MONTHS

NUMBER OF DOCUMENTS CREATED

NUMBER OF MEETINGS WITH CLIENT

Number of Document Reviews

Other Recent Projects

We love helping our clients to create the products and services that their customers really need, as well as the experiences and work cultures that differentiate them from competitors. See below other examples of our work in User Experience (UX), ISO Compliance and Strategy Consulting.

LET’S TALK ABOUT YOUR PROJECT

Contact Us

Ameliot works with all types of organisations: from multinational corporations through public organisations to startups with bold ideas. If you are working on an interesting project that you would like to discuss with us, then email anna@ameliot.com or call +44 1223 798380.

Alternatively, you can drop us a line by completing this form…