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Medical Devices
Regulation/Quality/ Management Systems 
Do you need as the manufacturer the regulatory support for the marketing of medical devices?
Yes, I do.
Are you ready for an inspection by the regulatory authority?
We can help you!
Do you need comprehensive legislative monitoring?
Yes, I do.
"Our advantage is professionalism and speed. We specialize in legislation of medical devices and regulation of MDR and IVDR. We implement quality management systems according to ISO 13485: 2016."

216

Current clients

12

Team members

7

Released publications

12 627

Number of MD which we already helped
Our success is the success of our customers.