Expert MDR & IVDR Consulting for Medical Device Compliance
Streamline your medical device journey. MDRcert provides comprehensive support for Technical Documentation, ISO 13485 QMS, Risk Management (ISO 14971), Clinical Evaluations, PMS, and Global Regulatory Strategy.
Ensure Regulatory Compliance
Accelerate Market Access
Mitigate Compliance Risks
Comprehensive Global Medical Device Regulatory & Quality Compliance Services
Expert Guidance Rooted in Real-World Experience
At MDRCert, our strength lies in our team of seasoned medical device professionals. We possess deep, hands-on expertise in navigating the complexities of EU MDR, IVDR, ISO 13485 quality management, and ISO 14971 risk management.
Our consultants leverage diverse backgrounds, including industry R&D and notified body experience, to deliver practical, effective compliance strategies tailored to your specific needs. We partner with manufacturers to simplify technical documentation, streamline regulatory submissions, and ensure ongoing post-market vigilance.
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Testimonials
Working with MDRCert for our MDR compliance audit was a game-changer. Their thorough risk management assessment helped us achieve Notified Body approval on the ...
Dr. James Rodriguez
MDRCert guided us through our complete IVDR transition with exceptional expertise. Their team identified critical gaps in our technical documentation and provid...
Sarah David
As a first-time manufacturer, the EU MDR felt overwhelming. MDRCert became our trusted partner, guiding us from initial strategy and risk management to final su...
Ben Smith
The gap analysis conducted by MDRCert was a game-changer. They identified critical vulnerabilities in our technical file before our notified body audit. Their a...
Thomas Wright
mplementing a compliant ISO 13485:2016 QMS seemed daunting. MDRCert provided clear, pragmatic guidance tailored to our small company’s needs. They didn...
Maria Rodriguez
MDRCert authored a comprehensive Clinical Evaluation Report for our Class IIb device. Their report was exceptionally thorough and meticulously structured, which...
David Chen
We engaged MDRCert for our full MDR transition strategy. Their team’s deep expertise, particularly their former notified body background, was invaluable. ...
Sarah Jenkins
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