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Frequently asked questions

We have compiled some of the most asked questions we receive. If there is anything else you'd like to know about what we do, please get in touch.

  1. We can work with the majority of medical device manufacturers seeking compliance of their devices in accordance with Regulation (EU) 2017/745, with the exception of dental implants, in-vitro diagnostic devices, orthopaedic devices and devices that exert their primary action through a pharmaceutical agent.

  2. No. We will work with you to produce RWE Generation Systems and to support your EU MDR compliance, but we do not conduct research ourselves. We will provide tools for you to conduct your own post-market surveillance. Our range of services are designed to assist you in this matter.

  3. Yes. We adhere to the highest standards of professionalism and regard maintaining confidentiality and data security as a cornerstone of our practice. We also comply fully with the requirements of GDPR.

  4. Our services are built around a strict quality framework and we only work with clients who share this commitment to quality. Our CEO is a medical doctor with years of experience in the medical device industry and assumes personal responsibility of every project. Our product development process integrates client feedback throughout product production, ensuring a constant focus on your needs.