Quality & compliance

Compliant, safe products tailored to the needs of healthcare professionals

SOFT Diffusion relies on certified industrial partners and a rigorous selection of products to guarantee quality, traceability, regulatory compliance and reliability of use.

Essential guarantees for reliable, compliant supplies

SOFT Diffusion relies on certified industrial partners to guarantee products that are compliant, documented and adapted to the requirements of healthcare professionals.

ISO 13485 certification

Manufacturing under a quality management system dedicated to medical devices.

  • Quality system dedicated to the medical sector

  • Controlled manufacturing and control processes
  • Traceability and document tracking

  • Certification by TÜV SÜD

CE marking

The products concerned comply with the European requirements applicable to their placing on the market, according to their nature and classification.

  • Compliance with applicable European requirements
  • Marketed in accordance with current regulations
  • Compliance with safety and performance requirements

MDR Certification 2017/745

Devices that comply with European regulations applicable to medical devices for the European market.

  • Compliance with European MDR regulation
  • Enhanced safety and performance requirements
  • References tailored to the European market
  • Assessment by notified body TÜV SÜD (0123)

Related documentation is available on request.

Do you have a query about the quality or conformity of our products?

Would you like to obtain technical documents, certificates or regulatory information on our products?
Our team is at your disposal to provide you with all the information you need, and to support you in the process.

Soft Diffusion

68 boulevard Carnot
06400 Cannes

Phone

+33 4 93 06 58 55
Monday to Friday, 9am to 12pm and 2pm to 5pm.

Email

contact@softdiff.com

Areas served

France & DOM-TOM | Europe | Africa