Rosti
Medical Device Contract Manufacturing
Every component we produce as a medical device contract manufacturer has a direct impact on patient health. That responsibility shapes our culture of precision, care and uncompromising quality at Rosti — one of the world’s trusted medical device contract manufacturing companies.
Your Trusted Medical Device Contract Manufacturing Partner: Concept to Serial Production
We specialise in high quality, precision plastic injection moulding and cleanroom manufacturing for the medical and pharmaceutical industries. With a strong focus on compliance, sustainability and innovation, we support customers from concept to reality across 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, industrialisation 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 programmes.
- 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 Centres providing advanced engineering, prototyping and problem solving to address complex customer challenges and accelerate time to market.
- Sustainability mindset: Sustainability integrated into design and production, supported by CSRD readiness, ISO based management systems and a clear commitment to shaping sustainable solutions for tomorrow.
ISO 13485 Certified Medical Manufacturing
Rosti’s commitment to quality and compliance is reflected in our global certifications and audited management systems.
These certifications ensure that our processes meet international standards and that our customers can trust the integrity of every component we produce, from initial qualification through to long term serial production.
Our medical manufacturing facilities meet the rigorous requirements of ISO 13485, an international standard for quality management systems in the medical device industry.
We maintain certified cleanroom facilities in accordance with ISO 14644-1, which establishes standards for air cleanliness in cleanrooms and controlled environments.
Our production environment ranges from ‘white room’ to certified cleanroom class7 & 8, ensuring that 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 of 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 spectrum 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 reflect our ability to scale from high volume diagnostics to lower volume, highly specialised 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 around the stringent demands of the healthcare industry and the expectations of regulators.
- Class 7 and 8 cleanrooms in multiple regions for sterile and particle controlled environments in line 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 moulding using advanced tooling, scientific moulding and automation for tight tolerances and repeatable results.
- Automated assembly and in line-testing to secure consistent quality, efficiency and reduced operator dependency for critical components.
- Tooling, prototyping and pilot production that shorten development cycles and de risk design transfer 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 Moulding 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 Medical Solutions
Certifications
Tailored Manufacturing at Global Scale: A New Standard for Medical and Pharmaceutical Production
In the medical and pharmaceutical sectors, manufacturing partners are expected to deliver far more than production capacity alone. Today’s customers require flexibility, regulatory consistency, scalability, and the confidence that their…
Cleanroom
Expanding global Cleanroom capabilities
Rosti is making significant investments in medical plastic injection moulding and cleanroom production capabilities across Europe, Asia, and North America. The medical device industry is evolving rapidly, with manufacturers under…
Contract Manufacturing
Producing over 50 million nutritional feeding set components through injection moulding each year
Nutritional Feeding sets are essential in modern healthcare, supporting the safe and efficient delivery of fluids, medicines, and nutrients to patients. These devices consist of several precisely engineered components, all…
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 delighted to announce the upcoming opening of new…
