Your Swiss specialist partner for FDA-compliant medical device manufacturing
Swiss quality for the US market
End-to-end manufacturing
Complete traceability and clear responsibilities
Iftest Medical Manufacturing AG (IMM) now adds medical device manufacturing services to its portfolio. We combine our expertise with the engineering capabilities of Iftest AG to provide a seamless service from product engineering and design transfer to the manufacture of Finished Devices for the US market.
Our services cover design transfer, supplier management, incoming inspection, manufacturing, testing & verification, labeling & packaging, and complete documentation and traceability.
As one of the few Swiss companies manufacturing Finished Devices in line with the FDA’s regulatory requirements under 21 CFR Part 820, we help MedTech companies transition their products to safe, efficient and consistent volume production for the US market.
Our ISO 13485-certified quality management system and documented, audit-ready manufacturing processes ensure compliance.
Our services
Design Transfer
IMM guides MedTech companies through a systematic design transfer process. We ensure that production is based on complete, traceable development data, specifications and quality requirements, and meets all applicable regulatory requirements.
This gives companies a controlled way to industrialize their products safely and efficiently.
Manufacturing
IMM provides a complete range of manufacturing services for medical devices and Finished Devices. Standardized processes, documented workflows and demanding quality standards support reliable, scalable and auditable manufacturing.
We are responsible for manufacturing in compliance with applicable standards and end-to-end traceability.
Testing
Our review processes focus on quality and patient safety.
Defined testing and verification procedures ensure that every product reliably and consistently meets the specified requirements.
We document every test result in full, making every result traceable and every process auditable.
Labeling & Packaging
As a contract manufacturer, IMM is functionally responsible for the finished medical device. That is why we provide labeling, product identification, and final packaging in compliance with regulatory requirements. We deliver each Finished Device complete with Labeling, Packaging, and all required documentation. Market-ready, fully traceable and managed end to end.
Industries
Our customers develop innovative products for regulated markets. IMM helps companies in medical technology, diagnostics, laboratory automation and related high-tech fields industrialize their products and move them into volume production for the US market.
Quality & Compliance
FDA registration (pending)
FAQ – frequently asked questions
Swiss engineering stands for precision, quality, and reliability around the world.
At Iftest Medical Manufacturing, you benefit from auditable processes, direct communication, dependable production and a manufacturing approach built around the regulatory needs of the medical technology sector.
We can handle both small and large production runs. We support MedTech companies from pilot projects and pre-production runs to scalable volume production. Our processes are designed to scale with your business and the demands of your market.
We specialize in electronic medical technology and support products such as:
- Diagnostic systems
- Wearables
- Monitoring systems
- Laboratory automation
- Medical electronics
Our experience with complex electronic systems and FDA-ready processes means we can support even the most demanding and safety-critical applications.
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