For many agencies ‘medical devices’ is a buzzword, but KO2 get to the heart of what recruitment in medical devices for electronics and embedded systems business really means. For our clients in the medical device sector who are new businesses/startups, finding candidates who have experience with the necessary medical standards is often essential during the initial recruitment stages.
At the embryonic stages of a medical device, KO2 have found medical device experts who can review the existing state of software and compile a list of corrective actions if required.
Our digital healthcare agency contains experts who help create IEC-62304 compliant SDLC whilst providing IEC62304 and SDLC training to relevant personnel within the business. They also ensure that IEC62304-compliant processes are executed in the company whilst introducing the infrastructure required for IEC-62304 SDLC. They might ensure ISO-14971 based software risk management is managed correctly and will investigate the potential RTOS solutions whilst creating the software framework to be used for future medical devices.
Medical device experts ensure that software requirements are based on high-level project/system requirements whilst allowing the design and implementation of software configuration items.