Reference

Accompaniment of MDR product licensing

The new European Medical Devices Regulation (MDR) means that the approval requirements for medical devices in Europe have changed considerably. EXCO is advising a medical device manufacturer on fundamental changes and requirements of the new regulation (EU) 2017/745 on medical devices and provides services for the legally compliant implementation of the new requirements for development, production and marketing processes.


EXCO Services
  • Consultation for MDR/IVDR innovations
  • GAP analysis QM system
  • Development and optimization of QM systems according to currently valid specifications
  • Risk management 14971
  • Employee training
  • Compilation of product-specific standards and guidelines
  • Creation of technical documentation
  • Audit support

Client benefits
  • Harmonized QM system
    The customer receives a QM system that is harmonized on the basis of DIN EN ISO 13485:2016 and the European Medical Devices Regulation (MDR) and which meets all applicable requirements.
  • MDR readiness
    Our EXCO-MDR specialists are available at short notice, which provides our customer with a knowledge advantage so that their product meets all regulatory requirements.
  • Optimized risk management
    As an experienced service provider for risk management according to ISO 14971:2019, EXCO provides its customers with support for risk management during the development and life cycle of a product.
  • Safe market launch
    EXCO’s knowledge guarantees the safe, efficient and timely marketing of the customer’s product.

Client

Manufacturer of medical devices

Expert contact

Stephan Blab

T+49 6233 73778-120