Welcome to SEQ Services, your trusted partner in Medical Device CE Marking Compliance. The Medical Devices Regulation (EU 2017/745) has replaced the Medical Devices Directive (93/42/EEC), bringing significant changes for manufacturers placing medical devices on the European Union market.
Key Points:
MDR Impact on Manufacturers: Understand the implications of the Medical Devices Regulation on all classes of medical products and the life-cycle approach to device regulation.
CE-mark Certification: From Class I self-application to Notified Body certification, SEQ assists you in navigating the regulatory pathway for your product.
PRRC Support: Ensure compliance with an identified Person Responsible for Regulatory Compliance (PRRC) with SEQ’s expert assistance in post-market surveillance and vigilance activities.
European Authorized Representative: Choose SEQ for assistance in selecting an independent representative dedicated to regulatory affairs, ensuring compliance with Competent Authorities.
Comprehensive Support: SEQ provides comprehensive support at every phase, ensuring your medical devices meet regulatory requirements.
Contact Us: For tailored solutions and expert regulatory assistance, contact SEQ at enquiries@nerin.co.im. Explore how SEQ can be your guide in achieving Medical Device CE Marking Compliance.
