The Medical Device Regulations (MDR) place strict regulatory obligations on medical device manufacturers that are straining company resources across the industry. We can help…
We offer a range of services to address all your MDR-compliance requirements
We are an alternative to recruiting extra regulatory staff at a fraction of the cost
We have years of professional experience and will meet your deadlines
- 360-degree lifecycle development of Real-World Evidence (RWE) generation systems
- Writing of CERs in accordance with MDR requirements, or updating of existing CERs to new standards
- ISO:14971-compliant Risk Analysis
- MDR-standard complaints handling
- A range of other services geared towards ensuring that your devices remain in market after May 2020
Our business is conducted in strict adherence to all relevant legislative, ISO, and global guideline standards.
Mantra Systems was founded by a senior medical affairs physician with extensive experience working for medical device manufacturers across the industry. Following a successful career in clinical medicine, the company founder undertook a degree in law before moving into the medical device industry.
The Mantra Systems team share the vision of the company founder - that of providing a superior service built around the highest standards to ensure continuity of availability of medical devices under the new MDR.
Mantra System's services are built around a strict quality framework and we only work with clients who share this commitment to quality. Our ethos is the highest standard of personalised professional services.
If you would like to discuss our services in more detail, please get in touch and we will get back to you as soon as possible.