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

The Gender Equality Index was established by the Law on the Freedom to Choose One’s Career Future. It is a tool designed to calculate the pay gap between men and women.
This index allows companies to assess the level of gender equality out of 100 points. It is calculated based on the following criteria:

  • Gap in pay between women and men
  • Gap in individual pay raise rates
  • Number of female employees receiving raises following maternity leave
  • Parity among the 10 highest paid employees
  • Gap in promotion rates

The VELFOR Group has calculated its Gender Equality Index. For 2024, it stands at 92/100:

  • Pay gap indicator: 37 points out of 40
  • Individual pay increase rate gap indicator: 35 out of 35
  • Return from maternity leave indicator: 15 out of 15
  • High pay indicator: 5 out of 10