Controls and qualifications

The Velfor Group has over 30 years of proven expertise in the healthcare sector, and works with major international accounts in the industry.

We have a large-scale production facility with three ISO 13 485 (v2016) certified sites featuring :

  • 2 ISO 7 thermo rooms
  • 1 ISO 8 thermo room
  • 7 rooms for ISO 8 production stages
  • 1 room for ISO 7 production stages
  • 3 HF ISO 8 welding rooms
  • 2 ISO 8 sealing rooms
  • 1 ISO 7 sealing room

This ISO 7 and ISO 8 cleanroom production environment, combined with our expertise in polymers, enables us to offer a wide range of multi-technology solutions to meet every specification.

We support your projects from A to Z:

From design development to the first production batch:

Assistance in defining requirements and associated risks throughout the project:

  • Advice on the choice of materials and suppliers, focusing on proximity, functionality, sterilization and economics

  • Common definition of your design

  • Tool design

Validation of the chosen solution :

  • Prototypes and/or models

  • Supplier qualification

Launch of industrialization :

  • Tooling launch

Bureau : 1 Identification des besoins / Étude du cahier des charges

We qualify your machines, tooling, materials and processes (thermoforming, packaging, sealing).

FAT (Factory Acceptance Test) / SAT (Site Acceptance Test), QC (for equipment), QI, QO and QP + comply with the latest versions of standards 13485 version 2029 and ISO 11607 – 1 and 2 version 2019.

We qualify machines, tooling and thermoformed parts, as well as blister sealing (traction, tightness and peelability) and packaging activities.

We can also verify the UDI (Unique Device Identification) of your DM.

We can also measure coefficients of friction, enabling us to characterize our raw materials. Useful in our innovation and qualification phases, in incoming inspection for critical materials, or in routine material investigation, for example.

In-process monitoring complies with our standards and is defined in the specifications. We retain the flexibility to set up customized monitoring of your production, according to your requirements.

For further information

Contact us
Quality approach