Starting a medical device company can be challenging. Apart from the expertise in the technology being developed, there is the overwhelming requirements needed for the company from a product development Design Control, requirements for a regulatory submission and the requirements for the Quality Management System (QMS). Most companies focus on the regulatory submission, creating time gaps in both Design Control and QMS. Without proper adherence to Design Control and a QMS in place, a new startup can be shutdown, be forced to remediat(or in the worst cases shut down), which can be extremely costly and time consuming. Even trying to catch up on all of the requirements, having postponed these components while focusing on your regulatory submission can add cost and time to your product launch. #engineering #automation

Thinking of your regulatory submission as part of the output of the Design Control process, putting the focus on the key components of your company and the product development process can not only save you time and money; it will lead to products that are better quality and meet the needs of your user.