GreenDale Medical Engineering searching as a continuous process “the simple solution on the product development documentation”. We know the regulatory requirements for medical devices and help you outlining the requirements for your product – creating the overview – establish the list of required documents – building the product documentation plan in compliance with Design Control Requirements.
Our core business relates to the Medical Device Product Development. We assist you in making the Medical Device Directive requirements transparent through building the documentation and regulatory overview. Our value contribution is based on experience from the Startup environment combined with “best in practice” experience from some of the leading Danish medical device companies.