Greendale Services

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.

We assist you in designing your product development process to be in compliance with harmonised quality management standards. Design Control is a must if you will register a medical device for sales.
We help you in the implementation process of your Quality Management System in accordance with ISO 13485 – setting up requirements to your organisation including training and education. Update and lean your processes to be in compliance with updated standards
We coach you or assist you with resources getting your technical product documentation (Design History File (DHF) / Technical File) in compliance with regulatory requirements.
We guide you in building your Risk Management file in compliance with ISO 14971 and ISO 13485 Risk Management shall be seen as an integrated part of concept development and the product development process. Risk Management is a dynamic and ongoing process in the life time of the product.
We offer you a third part technical review of your product development project, ensure compliance to regulatory requirements.

Wanna connect?

Fill out the form

Your name (required)

Your e-mail (required)

Subject

Your message