Home
Services ﹀
Clinical evaluation EU Authorised representative Notified bodies Post-market surveillance PRRC Quality management system Risk management Technical documentation
Devices﹀
General medical devices and equipment In vitro diagnostics Medical software
Articles About Contact us

Send us an email:
info@mdrc-services.com

Or use the contact form below

 
Technical documentation EU Authorised representative Clinical evaluation PRRC services Risk management Notified bodies Quality management system Post-market surveillance
General medical devices and equipment In vitro diagnostics (IVD) Medical Device Software (MDSW)
CE-marking process for medical devices CE-marking process for in vitro diagnostics MDR technical documentation checklist IVDR technical documentation checklist Technical documentation checklist for MDSW PRRC under MDR or IVDR
CE-Certificate vs. EC-Certificate Basic UDI-DI (bUDI) EUDAMED registration - a brief guide Read more >>

EU Company specialising in EU Medical Device Regulatory Compliance




Enabling compliance with EU Regulations for medical and in vitro diagnostic devices.

Learn more

Our services at a glance

Authorised representative

EC REP for non-EU medical device companies.

Technical documentation

MDR- or IVDR-compliant technical files for your products.

Clinical evaluation

Clinical evaluation for any classes and types of medical devices/IVDs.

PRRC

Person Responsible for Regulatory Compliance under MDR and IVDR.

Risk management

Robust risk management processes tailored to your products.

Notified bodies

Communication with NBs throughout the regulatory process.

QMS

Tailored solutions to address QMS non-compliance issues.

Postmarket surveillance

Systems for monitoring safety and performance of medical devices.

Talk to a specialist

360° services around the CE-marking


We offer a complete range of solutions that cover every aspect of the CE-marking process. From developing compliant technical documentation to serving as your authorised representative, we ensure compliance with European regulations.

Both MDR and IVDR covered


We offer services that cover both the Medical Device Regulation and the In Vitro Diagnostic Regulation.Our solutions ensure that you receive expert guidance and support for compliance with both MDR and IVDR requirements.



Learn more

Our solutions simplify your regulatory effort


With our solutions, you can save time, reduce administrative burden, and focus on what matters most – developing and delivering exceptional medical devices.



Send us an email:
info@mdrc-services.com

Or use the contact form below