If not, SFL can support you to turn the response into a confident “yes” within the required timelines.
Led by two former heads of notified bodies, SFL’s medical device and combination products teams are creating, reviewing and updating technical and clinical documentation and quality management systems according to MDR 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 including medical doctors and PhDs, can support your MDR implementation project by performing gap analyses, proposing effective strategies and providing hands-on support with all aspects of MDR 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 assessment under the MDR. 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.
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