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Zdravotnické prostředky Porta Medica MDR
Medical Devices
Regulation / Quality / Management Systems 
Do you need as the manufacturer the regulatory support for the marketing of medical devices?
Yes, I do.
Do you need help keeping the resource
on the EU market in terms of MDR and IVDR?
Yes, I do.
Are you updating a clinical evaluation? Are you planning a clinical trial?
Yes, we need help.
Do you need to get reimbursement from the public health insurance for your device?  
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 the legislation of medical devices and regulation of MDR and IVDR. We implement quality management systems according to ISO 13485: 2016."
Zdravotnické prostředky Porta Medica MDR

296

Current clients

14

Team members

8

Released publications

13 157

Number of MD which we already helped
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