Plastisart specialises in the design and manufacture of plastic parts and assemblies for the indu...
Plastics for the Medical & Healthcare Sector A plastic subcontractor that understands the requirements of the medical sector
Manufacturing plastic parts for medical devices and healthcare equipment
The medical and pharmaceutical sector is one of the most demanding for a plastic subcontractor. Material traceability, dimensional precision, material biocompatibility, compliance documentation and series repeatability are not options: they are non-negotiable prerequisites that the specifications impose from the very first part.
At Plastisart, we work with medical equipment manufacturers, laboratory device manufacturers and pharmaceutical equipment manufacturers who need technical plastic components produced with the level of rigour this sector demands. Our integrated design office, precise transformation processes and documented quality approach allow us to meet these requirements without any break between the design phase and series production.
The technical requirements of medical plastics
Biocompatibility of materials
Parts in direct or indirect contact with patients, biological fluids or medications must be manufactured from clinically inert certified materials. At Plastisart, we work with medical grades of PEEK, PA, POM, PC, PMMA, HDPE and PP that meet the strict requirements of USP Class VI and ISO 10993. The exact grade is validated from the study phase by our design office.
Sterilisability
Depending on the sterilisation method chosen, steam autoclave, gamma radiation, ethylene oxide (EtO) or plasma, thermoplastics react differently.
- PEEK and PTFE withstand repeated autoclave cycles at 134°C without deformation.
- Polycarbonate (PC) and PMMA tolerate gamma radiation perfectly but cannot withstand the high temperatures of steam. This in-depth knowledge of material behaviour in relation to sterilisation protocols is integrated into our advice during the design phase.
Complete traceability
Every batch of medical parts produced in our workshops is subject to documented traceability from the raw material through to delivery: material reference and certificate (2.1 or 3.1), key production parameters, dimensional and visual inspection results, and operator identification. This technical documentation is provided to you with every delivery.
Dimensional precision
Medical devices frequently incorporate complex architectures — sealed assembly interfaces, locking systems, sensor housings — that impose tight tolerances. Our CNC machining park with 3 and 5 axes allows us to guarantee this geometric accuracy and document it through comprehensive inspection reports.
Regulatory documentation
For projects subject to the European regulation on medical devices (MDR 2017/745) or pharmaceutical requirements (GMP/BPF), we provide the necessary compliance documents: material certificates 2.1 and 3.1, USP Class VI certifications, FDA reports, safety data sheets.
Design and prototyping
- Comprehensive support, from design to industrialization
- Detailed identification of your technical needs
- Advice on the choice of the most suitable technologies
Medical and pharmaceutical applications at Plastisart
Thanks to the complementarity of our production equipment, we cover a broad spectrum of custom medical plastic parts :
Imaging and diagnostic equipment
The covers, cladding and protective structures of scanners, MRI machines or ultrasound devices incorporate thermoformed or RIM-injected parts in ABS or PC. Their visual appearance, dimensional precision and resistance to hospital cleaning protocols are critical.
Surgical instruments and accessories
We handle the machining of gripping handles, tool handles, cutting guides and components for reusable instruments. PEEK, medical PA and PPSU are preferred here for their rigidity and excellent resistance to autoclave cycles.
Laboratory and analysis equipment
Plastisart produces technical trays, transport racks, pipette holders and tanks for analysis automates. Medical POM, HDPE and food-grade PP are used for their near-zero porosity and resistance to solvents.
Pharmaceutical distribution and dosing devices
We manufacture to drawing pump bodies, dosing pistons and rotary valves. These precision parts, often machined in PTFE, guarantee the absence of particulate contamination and perfect chemical neutrality with respect to active substances.
Medical structures and furniture
The barriers of medical beds, care trolley shells and remote control claddings incorporate large-dimension plastic components combining high mechanical resistance and refined aesthetics.
Why choose Plastisart for your medical devices?
physical constraints of each application. Thanks to our proven experience, the precision of our CNC machining centres and our documentary rigour, Plastisart is positioned as the partner of choice for healthcare equipment manufacturers.
At Plastisart, this protocol systematically integrates first part validation (First Article Inspection, FAI), statistical control during manufacturing, final inspection and batch documentation. For projects subject to strict regulatory requirements (MDR 2017/745, GMP/BPF), we make available to you all the required documentation (REACH, RoHS, FDA certificates) and we adapt to your audit and supplier qualification procedures.
