Compliant end-user feedback for MedTech

Purpose and goal:

ResearchOnTheGo (ReGo) offers a platform for the collection and management of user feedback for the MedTech industry. In this project we have validated the need for ReGo´s solution together with pilot customers, performed a regulatory compliance review and established a regulatory compliance strategy for our solution in accordance with the EU General Data Protection Regulation and the EU Medical Device Regulation.

Expected results and effects:

The activities of this project have led to an improved data protection policy as well as templates for data processing agreements and other documents needed for the commercialization of the platform. We have also compiled a list of requirements from our pilot customers to guide the further development of our platform. These results are important in our discussions with potential investors.

Approach and implementation:

Project activities were conducted by ReGo with support from consultants with considerable experience of quality management systems and regulatory affairs for medical devices and pharma, data protection legislation as well as legal contracts, user experience management and service design.