The clients of DRS are global manufacturers of complex medical devices. We have given advise regarding the development of implants, pacemakers, neuro-stimulators, medical software (for example apps and cyber security) and devices for the treatment of complex wounds. Moreover, we have added a large number of small and medium-sized organizations with innovative products to our clientele.
Some of our products and services for our global customer base:
- CE submission files (AIMD, MDD and IVD).
- 510 (k) submission files.
- Audits for scrutiny and regulation.
- Clinical strategies for the introduction of high-risk medical devices in the United States.
- Regulatory Affairs strategieën voor ontwikkeling en productie.
- Trainingen in EU medical Device Regulations.
- Trainingen in klinisch onderzoek voor medische hulpmiddelen.
- Trainingen m.b.t. Medical Software