French industry

Medical

Balancing therapeutic innovation with strict regulatory requirements, the medical sector demands an unparalleled level of rigor from manufacturers, where biocompatibility, traceability, and patient safety leave no room for error.

With our 550 m² ISO 8 cleanroom and ISO 13485 certification, we manufacture LSR and HRC silicone components for medical devices and pharmaceutical processes, in strict compliance with the sector's biocompatibility and traceability requirements.

ISO 9001

Quality Management System

Certification

ISO 13485 - USP Class VI

Industry challenges

Technical challenges in the sector

It is used in various sectors due to its exceptional technical properties.

Regulatory compliance for medical devices

Any silicone component integrated into a classified medical device is subject to the European MDR 2017/745 regulation, which mandates proof of biocompatibility, full traceability, and an ISO 13485-certified quality management system. The supplier must be able to provide a complete technical file, biocompatibility data according to ISO 10993, and documented control of their manufacturing process.

Biocompatibility and material non-toxicity

When in contact with the human body or biological fluids, a silicone elastomer must be free of any substance capable of causing a cytotoxic reaction, sensitization, or irritation. The formulations used must be tested according to the ISO 10993 series and meet USP Class VI requirements for the most critical applications. The choice of catalyst—platinum or peroxide—has a direct impact on the toxicological profile of the finished part.

Manufacturing in a controlled atmosphere and particulate contamination control

Manufacturing parts for medical devices or pharmaceutical processes requires a controlled production environment to limit particulate and microbiological contamination. Progress Silicones operates a 550 m² ISO 8 cleanroom for extrusion and molding (LSR and HRC), staffed by 12 operators trained in medical sector requirements.

Batch traceability and document management for medical device technical files

Compiling the technical file for a medical device requires that every component be exhaustively traced: material reference, batch number, manufacturing parameters, and inspection results. Any change in formulation, raw material supplier, or process must be notified to the client and undergo a conformity reassessment.

Area of application

Advantages of silicone

It is used in various sectors due to its exceptional technical properties.

Isothermal

40°C to 200°C and can reach -110°C and +315°C with additives.

Adjustable hardness

Shores from 1 Shores A to 90 Shores A and mosses

Respecting current standards

our blends are REACH and ROHS

Resistant to the elements

UV/saline environments

Colourable to order

RAL Pantone & countertyping

Compatible with the electrical environment

insulator or conductor

Durable

long product life

Adaptable

industrial or medical sector

See the case study

Year

Medical

Sector

Parts

Expertise

Practical applications

Peristaltic tubing for infusion pumps
Valve membranes for medical drainage devices
Syringe and cartridge seals for injection systems
Respiratory masks and patient interfaces
Tubing and sleeves for dialysis equipment
Silicone components for laboratory automation systems

Industry standards & certifications

ISO 13485

Quality management system specific to medical devices—a mandatory requirement for any supplier of components integrated into a classified medical device. Progress Silicones is ISO 13485 certified.

ISO 10993 / USP Class VI

A series of standards for the biological evaluation of medical devices (cytotoxicity, sensitization, irritation) and the USP benchmark for biocompatibility—Progress Silicones holds Biocomp 10993 and USP Class VI certifications.

MDR 2017/745

European Medical Device Regulation, in effect since May 2021—defines the traceability, biocompatibility, and technical documentation requirements applicable to silicone components integrated into classified medical devices.

Services

Our expertise at the service of your project

From the study phase, our teams can support you in order to find the solution perfectly adapted to your needs/sector of activity. We then define the best manufacturing process.

Design office

Our teams support you from the design of your plans, technical choices and tool manufacturing.

Molding

We design a unique custom mold according to the specifications drawn up with the customer.

Extrusion

This precise manufacturing process consists in pushing silicone through a die with a simple or complex shape.

Confection

Assembly, vulcanization, welding for tailor-made products.

Our differentiation

Our expertise in the medical sector

We have an ISO 8 class clean room with an area of 550 m², of which 250 m² are devoted to extrusion and 300 m² to moulding, which constitutes 20% of our business.

FAQ

We answer your most frequently asked questions

Are you ISO 13485 certified for the manufacturing of medical device components?

Yes. Progress Silicones is ISO 13485 certified and operates a 550 m² ISO 8 cleanroom dedicated to the production of components for classified medical devices and pharmaceutical process products. Our entire quality management system is structured to meet the documentation requirements of MDR 2017/745.

Are your materials ISO 10993 and USP Class VI compliant?

Yes. We hold Biocomp ISO 10993 and USP Class VI certifications for our silicone formulations produced in a cleanroom. The corresponding certificates are provided with every delivery. For applications requiring biocompatibility testing specific to your technical file, we can refer you to an accredited partner laboratory.

What is the difference between platinum-cured and peroxide-cured silicone for medical applications?

Platinum curing (LSR or platinum HCR) is recommended for medical applications in contact with the human body or biological fluids. It leaves no catalyst residues that could migrate and offers a superior biocompatibility profile. Peroxide curing requires mandatory post-curing to eliminate vulcanization by-products.

Can you produce compliant colored parts for medical devices?

Yes. We offer ISO 10993 and USP Class VI compliant colored compounds, produced in a cleanroom. Coloring can meet needs for hardness coding, part differentiation, or visual identification in clinical settings. The pigments used are selected for their biological safety and long-term stability.