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 EU MDR/IVDR implementation for medical devices (including software), combination products and in vitro diagnostics [IVDs] (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.
