Medical Device Contract Manufacturing

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

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

Absolutely. We provide design, tooling, and prototyping services to help customers speed up development and shorten time-to-market.

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

We run Class 7 & 8 cleanrooms worldwide (currently in China, Poland, Turkey, and the USA), suitable for a broad range of medical and diagnostic applications.

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

For Rosti, staying agile in today’s fast-paced, ever-changing development cycles is essential. That’s why Rosti is one of the few companies equipped to leverage the latest advances in 3D printing. By utilizing Carbon® M3 printers and Digital Light Synthesis printing technology, we shorten lead times for prototype part testing, empowering our customers to speed up their time to market. Integrating 3D printing with traditional injection molding enables rapid prototyping and the development of more complex designs and geometries.

Our dedicated innovation team works closely with customers, offering solutions early in the development process to improve manufacturability and add value.

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

In conclusion, our innovation centers act as the engine fueling our commitment to excellence and ongoing improvement. By embracing state-of-the-art technologies, promoting collaboration, and staying in tune with market changes, we help our customers navigate the complexities of the medical industry with confidence and agility. Looking ahead, we remain committed to pushing boundaries, delivering innovation, and creating value for both our customers and partners.

As a leading CMO, our Medical division provides a comprehensive range of services supported by regulatory expertise, innovation, and a strong focus on sustainability.

At the heart of our value proposition is our deep understanding of regulatory frameworks, ensuring we meet the highest standards of safety and efficacy. By making strategic investments in R&D, we continually push the limits of innovation, working closely with our customers to turn ideas into real-world solutions. Whether it’s developing new technologies or optimizing existing designs for manufacturability, our team is ready to deliver innovation at every stage of the product lifecycle.

Our commitment to sustainability goes beyond compliance, taking a proactive approach to environmental stewardship and embracing a networked strategy to address emissions. From lightweighting initiatives to sustainable materials and designs for recyclability, we aim to provide sustainable solutions for our customers to reduce our environmental impact while maximizing value for them.

Through collaborative problem-solving and a focus on manufacturability, we empower our customers to achieve their vision and advance progress in the healthcare industry. With a global presence and scalable capabilities, we are ready to support their entry into new markets and ensure supply continuity for long product life cycle programs. By serving as a key supply chain partner, we enable our customers to focus on what they do best – driving innovation and improving patients’ lives.

What truly sets our Medical division apart is its commitment to exceeding regulatory standards. With a strong focus on the strict requirements such as the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) in Europe, our team of dedicated professionals ensures that both our processes and products consistently meet and surpass industry expectations.

Additionally, when working with our Medical Solutions Team, you’ll have access to a group fully dedicated to bringing your medical device to life, from concept to reality. From R&D to project management and production, our Medical Solutions Team can support you at every step of the process.

The Medical Solutions division ensures a customer-focused and personalized approach to every project in order to achieve the highest quality standards and meet customer deadlines.

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

To determine the right classification, we assess your product’s clean room injection molding requirements, including material selection, exposure risk, downstream sterilization, and applicable regulatory standards. This makes sure the clean room environment is appropriate without adding unnecessary complexity or cost.

An effective injection molding clean room design is centered on contamination control and process stability. Key design features include:

• HEPA filtration systems to control airborne particles
• Positive air pressure to prevent contaminants from 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 molding in clean room operations.

Yes. We manage the entire validation lifecycle for cleanroom molded 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 cleanroom injection molding standards, providing full traceability to support regulatory submissions and audits.

Yes. While both processes require controlled cleanroom environments, cleanroom LSR Injection Molding involves additional technical considerations. Liquid Silicone Rubber requires specialized 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 factor for clean room precision injection molding. The controlled environment greatly reduces particulate contamination and process variability, both of which can affect 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 that require micron-level tolerances.