Achieve conformity and compliance of your products and documentation.
Combining Notified Body and industry insights with long-term experience in implementing regulatory requirements, SFL’s medical device and combination products team can support you with all aspects of MDR/IVDR implementation for medical devices (including software), combination products and in vitro diagnostics (including companion diagnostics, genetic tests, and near-patient testing devices).
SFL’s experienced cross-functional teams perform gap analyses and create, review and update technical documentation, clinical performance evaluation as well as quality and risk management systems according to MDD, MDR and IVDR requirements.
Don’t miss the MDR implementation – it is postponed (26 May 2021) but not revoked; and IVDR implementation follows shortly thereafter on 26 May 2022.
