challenge
Our client, a global contract manufacturer, was expanding their engineering capabilities into the medical device industry and lacked the experience to develop software in accordance with IEC 62304 required for FDA approval. In a risk assessment, their end customer had rated software as the highest risk component of the overall development and manufacturing effort.
solution
Randstad Engineering Solutions was able to leverage its decades of experience in the development of safety-critical software to bring leadership and guidance to our customer in completing the software per the applicable standards. Key elements of our solution included:
- deploying a team of senior resources to the client’s site to jointly identify and map the project scope, deliverables, required development standards and more
- providing technical leadership and a team of software resources to integrate with our client's team to ensure proper development of the software and corresponding artifacts
- planning and tracking of project metrics using a proprietary online tracking tool
outcome
Randstad Engineering Solutions was able to help our client meet and exceed their customer's expectations, including:
- moving software from the highest risk component to the lowest, in less than six months
- successfully meeting an aggressive project delivery schedule
- enabling our client to leverage this success to expand their presence in the medical device industry
