Our client needed assistance with their submission to an EU Notified Body. They asked Sunrise to provide guidance and practical advice on how to implement an IEC-62304 compliant software development process and identify which deliverables provide objective evidence of the development process being followed.
Sunrise Labs Solution
- Reviewed existing software lifecycle process and infrastructure/framework including quality assurance tools
- Provided guidance to improve/correct the existing process in order to be compliant with IEC-62304
Sunrise Labs analysis and recommendations for improvements and forward strategy were provided to the client within an extremely short time period to meet the clients business objectives. Our consultants remained “on call” for follow-up and clarifications and the client was extremely satisfied with Sunrise responsiveness, agility and quality.
Check out the V&V Remediation Support case study