Medical Startups – IEC62304 Standard Implementation
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 IEC62304 standard requires all aspects of the software development life cycle to be scrutinised, including:
- Risk management
- Problem resolution, and
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
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