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Medical Devices, Combination Products & 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 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.

  • Services

  • Regulatory Affairs
  • Quality Assurance & GxP Compliance
  • Medical Affairs & Communication
  • Market Access & Reimbursement
  • Public Affairs & Regulatory Intelligence
  • Medical Devices, Combination Products and IVDs
  • Pharmacovigilance & Clinical Safety
  • Supply Chains of Medicines and Devices
  • 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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