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Medical devices, combination products and IVDs

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.

Make sure you are compliant with the newly entered into force MDR and don’t miss the IVDR’s entry into application on 26 May 2022.

  • Services

  • Regulatory Affairs
  • Quality Assurance
  • Medical Affairs
  • Market Access
  • Public Affairs
  • Devices, combination products, IVDs
  • Pharmacovigilance
  • Supply Chain
  • Legal & healthcare compliance
  • Swiss Support
  • UK Support
  • Clinical Trials support

Switzerland – Main Office

SFL Regulatory Affairs & Scientific Communication GmbH
Aeschenvorstadt 52 | CH-4051 Basel
Email: office@sfl-services.com
Phone: +41 61 361 9443

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