MDR implementation: Is your company ready for the MDR applying from May 26th, 2021?
MDR implementation is only postponed (26 May 2021) but not revoked; and IVDR implementation follows en suite on 26 May 2022
SFL’s medical device and combination products teams are creating, reviewing and updating technical and clinical documentation and quality management systems according to MDR/IVDR requirements for our clients.
We cover the entire range of medical devices, including software, and of combined products, i.e. devices with an ancillary medicinal product, medicinal products with integral device components and co-packaged combined products.
SFL’s experienced cross-functional teams support your MDR/IVDR implementation project by performing gap analyses, proposing effective strategies and providing hands-on support with all aspects of MDR/IVDR implementation to achieve compliance.
Our in-house cross-functional expertise includes Regulatory Affairs, Quality Management, Supply Chain, Clinical Evaluation & Investigation, Post-Marketing and Tailored Training.
Take advantage of SFL’s extensive experiences to get ready for your conformity. We would be happy to set up a 30-minute call or meeting free of charge to discuss your project and how we could support you.