Medical Injection
Moulding Solutions

Our production systems include full traceability and validation protocols, ensuring every part meets regulatory and customer requirements.

We work with a wide range of medical-grade thermoplastics, including bio-based and recyclable options to support sustainability goals.

Absolutely. We offer design, tooling, and prototyping services to help customers accelerate development and reduce time-to-market.

Yes, our medical production facilities are ISO 13485 certified, ensuring compliance with global medical device standards.

We operate Class 7 & 8 cleanrooms globally (currently in China, Poland, Turkey, and USA), suitable for a wide range of medical and diagnostic applications.

In the fast-paced world of the medical industry, our innovation centres play a pivotal role in supporting our customers to stay ahead of the curve.

Key for Rosti is to remain agile in today’s fast-paced, ever-evolving development cycles. That’s why Rosti is one of the few companies equipped to harness the latest advances in 3D printing. By utilising Carbon® M3 printers and Digital Light Synthesis printing technology, we reduce lead times for prototype part testing, empowering our customers to accelerate their time to market. Integration of 3D printing with traditional injection molding allows for rapid prototyping and the development of more complex designs and geometries.

Our dedicated innovation team collaborates closely with customers, offering solutions early in the development process to increase manufacturability and create additional value.

We stay ahead of industry trends by investing in R&D and adhering to technical roadmaps inspired by NASA technology readiness levels (TRLs). This ensures our readiness to address evolving customer needs while maintaining close relationships with suppliers.

In conclusion, our innovation centres serve as the engine driving our commitment to excellence and continuous improvement. By embracing cutting-edge technologies, fostering collaboration, and staying attuned to market dynamics, we support our customers in navigating the complexities of the medical industry with confidence and agility. As we look to the future, we remain steadfast in our dedication to pushing boundaries, delivering innovation, and driving value for our customers and partners alike.

As a leading CMO, our Medical division delivers a comprehensive suite of services underpinned by regulatory expertise, innovation, and sustainability focus.

At the core of our value proposition lies our deep understanding of regulatory frameworks, ensuring compliance with the highest standards of safety and efficacy. Through strategic investments in R&D, we continuously push the boundaries of innovation, collaborating closely with our customers to translate ideas into tangible solutions. Whether it’s developing technologies or optimizing existing designs for manufacturability, our team stands ready to deliver innovation at every stage of the product lifecycle.

Our commitment to sustainability extends beyond mere compliance, encompassing a proactive approach to environmental stewardship, and embracing a networked approach to tackle emissions. From light weighting initiatives to sustainable materials and designs for recyclability, we strive to offer sustainable solutions to our customers to minimize our environmental footprint while maximizing value for our customers.

Through collaborative problem-solving and a focus on manufacturability, we empower our customers to realize their vision and drive progress in the healthcare industry. With a global footprint and scalable capabilities, we stand ready to support their expansion into new markets and ensure continuity of supply on long-life cycle programs. By functioning as a critical supply chain partner, we enable our customers to focus on what they do best – driving innovation and improving patients’ lives.

What truly distinguishes our Medical division is its commitment to surpassing regulatory standards. With a keen focus on stringent requirements such as the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) in Europe, our team of dedicated professionals ensures that our processes and products consistently meet and exceed industry expectations.

As well, when dealing with our Medical Solutions Team, you’ll have access to a team entirely dedicated to bring your medical device to live from concept to reality. From R&D to project management and production, our Medical Solutions Team can support you at any step of the process.

The Medical Solutions division ensures a Customer Focused and tailored approach to every single project to achieve the highest quality standards as well as meeting Customer’s deadlines.

The required clean room classification is determined by your product’s intended use, risk profile, and regulatory requirements. High-risk, implantable, or critical-path medical components typically require an ISO Class 7 environment, while lower-risk or non-patient-contact components may be suitable for ISO Class 8.

To define the correct classification, we assess your product’s clean room injection moulding requirements, including material selection, exposure risk, downstream sterilisation, and applicable regulatory standards. This ensures the clean room environment is appropriate without introducing unnecessary complexity or cost.

An effective Injection moulding clean room design is built around contamination control and process stability. Key design features include:

• HEPA filtration systems to control airborne particulates
• Positive air pressure to prevent contaminants entering the clean room
• Controlled zoning and material flow to separate clean and non-clean areas
• Non-contaminating machinery and materials designed for medical manufacturing

These elements work together to maintain consistent environmental conditions and support reliable Injection Moulding in Clean Room operations.

Yes. We manage the full validation lifecycle for clean room moulded components. This includes comprehensive documentation of:

• Installation Qualification (IQ)
• Operational Qualification (OQ)
• Performance Qualification (PQ)

These validation activities ensure that processes are controlled, repeatable, and compliant with relevant clean room injection moulding standards, providing full traceability to support regulatory submissions and audits.

Yes. While both processes require controlled clean room environments, clean room LSR Injection Moulding involves additional technical considerations. Liquid Silicone Rubber requires specialised metering and mixing equipment, along with precise control of temperature, pressure, and curing conditions.

Because LSR components are often used as seals, membranes, or flexible medical parts, even minor contamination can compromise performance. Maintaining a clean environment is therefore critical to preserving material integrity and ensuring consistent part quality.

Yes. Achieving tight tolerances is often a key driver for clean room precision injection moulding. The controlled environment significantly reduces particulate contamination and process variability, both of which can impact dimensional accuracy.

Our clean room facilities are equipped with advanced tooling, process controls, and monitoring systems that enable the production of highly precise medical components, including parts requiring micron-level tolerances.