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Grow Your Business With MDR Compliance
I help Medical Device companies – from startups to enterprises- comply with EU MDR 2017/745 and get ISO 13485 certified. Get assistance with 510K clearance, Technical files, and registration with regulatory bodies.
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Consultation
Understand MDR
ISO 13485
510K Clearance
MD Technical File
RA Registration
EU MDR 2017/745
The EU MDR 2017/745, or European Union Medical Device Regulation, is a comprehensive set of regulations governing the production and distribution of medical devices within the European Union. Enforced since May 26, 2021, it replaced the earlier Medical Device Directive. The primary objective of the EU MDR is to elevate the safety and efficacy standards of medical devices.
Classification system
Increased security
Post-Market Surveillance
UDI
Clinical Evaluation
Transparency & Traceability
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