Rosti
Medical Device Contract Manufacturing
Every component we produce as a medical device contract manufacturer directly impacts patient health. That responsibility shapes our culture of precision, care, and uncompromising quality at Rosti—one of the world’s most trusted medical device contract manufacturing companies.
Your Medical Device Contract Manufacturing Partner:
Concept to Serial Production
We specialize in high-quality precision plastic injection molding and cleanroom manufacturing for the medical and pharmaceutical industries. With a strong focus on compliance, sustainability, and innovation, we assist customers from concept to reality throughout the entire product lifecycle.
Customer-centric approach: Long-term partnerships with leading medical and pharmaceutical brands, built on transparency, trust, and shared responsibility for patient safety.
End-to-end support: From early design input, tooling, and prototyping through validation, industrialization, and full-scale medical device contract manufacturing.
Global footprint: Production in North America, Europe, and Asia, including expanding medical operations and cleanrooms in Poland, China, and the United States. This enables regional supply, dual sourcing, and resilience for critical programs.
Cleanroom production: Class 7 and 8 cleanroom manufacturing environments across key sites, suitable for a wide range of medical devices, diagnostics, and pharmaceutical packaging.
Relentless focus on quality: A unified global quality management system built over decades, operating under ISO 13485 and aligned with FDA 21 CFR 820 and EU MDR requirements for medical devices.
Innovation and engineering strength: Three Innovation Centers providing advanced engineering, prototyping, and problem-solving to tackle complex customer challenges and speed up time to market.
Sustainability mindset: Sustainability is integrated into design and production, supported by CSRD readiness, ISO-based management systems, and a clear commitment to developing sustainable solutions for the future.
ISO 13485 Certified Medical Manufacturing
Rosti’s dedication to quality and compliance is demonstrated by our global certifications and audited management systems.
These certifications ensure that our processes meet international standards, and our customers can trust the integrity of every component we produce, from initial qualification through long-term serial production.
Our medical manufacturing facilities meet the strict requirements of ISO 13485, an international standard for quality management systems in the medical device industry.
We operate certified cleanroom facilities in compliance with ISO 14644-1, which sets standards for air cleanliness in cleanrooms and controlled environments.
Our production environment ranges from a ‘white room’ to certified class 7 & 8 cleanrooms, ensuring we can meet the specific requirements of your medical device.
Our NPI procedure covers both new product development and existing product transfers, with defined gates, start conditions, scope, and goals overseen by a steering group.
All our tools, equipment, and production processes are validated through Rosti’s standard validation routine with IQ, OQ, PQ, or according to specific customer requirements.
Serving the world’s most trusted medical and pharmaceutical brands
Rosti supports OEMs and Tier 1 suppliers across a wide range of medical and pharmaceutical applications, including:
- Medical devices and components
- Diagnostics, consumables, and labware
- Pharmaceutical and drug delivery packaging
- Consumer health and self-care products
Our customers include global leaders who rely on Rosti for quality, reliability, and innovation. These partnerships show our ability to scale from high-volume diagnostics to lower-volume, highly specialized devices while maintaining consistent compliance and performance.
Our facilities are equipped to handle complex geometries, multi-material parts, tight tolerances, and high-volume production in line with global regulatory expectations.
Medical Device Contract Manufacturing Capabilities: Diagnostics, Pharma & Cleanroom Production
Rosti’s medical manufacturing capabilities are designed to meet the stringent demands of the healthcare industry and regulatory expectations.
- Class 7 and 8 cleanrooms in multiple regions for sterile and particle-controlled environments that comply with ISO standards.
- ISO 13485 certified production for medical device quality assurance, supported by documented procedures, risk management, and continuous improvement.
- High-precision plastic injection molding using advanced tooling, scientific molding, and automation for tight tolerances and repeatable results.
- Automated assembly and in-line testing to ensure consistent quality, efficiency, and reduced operator dependency for critical components.
- Tooling, prototyping, and pilot production that shorten development cycles and reduce risk when transferring design into full-scale manufacturing.
- Traceability and validation systems that support regulatory audits and customer requirements, including batch-level traceability, validation documentation, and robust change control.
Thought Leadership in Medical Device Contract Manufacturing and Cleanroom Production
This section will be continuously updated to reflect new developments, investments, and thought leadership. We regularly share insights and updates to help our customers stay informed, compliant, and inspired. Explore our latest content:
- Global Insight: Medical Molding by Gustav Reingsdahl – a deep dive into trends and technologies shaping the future of medical plastics and contract manufacturing.
- Cleanroom Investment in Rosti Poland – expanding our Class 8 cleanroom capacity to meet growing diagnostic and pharma demand.
- Blog posts on sustainability, compliance, and innovation in medical manufacturing, aligning with Rosti’s sustainability commitments and 2030 goals.
Case studies and posts within Rosti Medical Solutions
Certifications
Customized Manufacturing on a Global Scale: Setting a New Standard for Medical and Pharmaceutical Production
In the medical and pharmaceutical sectors, manufacturing partners are expected to deliver much more than just production capacity. Today's customers require flexibility, regulatory consistency, scalability, and the assurance that their…
Cleanroom
Expanding global cleanroom capabilities
Rosti is making significant investments in medical plastic injection molding and cleanroom production capabilities across Europe, Asia, and North America. The medical device industry is evolving rapidly, with manufacturers under…
Contract Manufacturing
Injection Moulding over 50 million Nutritional Feeding Set Components Annually
Nutritional Feeding sets are critical in modern healthcare, enabling the safe and effective delivery of fluids, medications, and nutrients to patients. These devices comprise multiple precision-engineered components, each of which…
Cleanroom
Rosti North America Expands Medical Manufacturing Capabilities with New ISO Class 8 Cleanrooms in Wisconsin and Utah
New cleanroom investments strengthen Rosti’s support for regulated medical and life sciences customers and position the company for continued growth. We are excited to announce the upcoming opening of new…
