Quality at the heart of everything
we do
For IMM, quality means more than complying with standards and regulations.
It is the backbone of safe medical devices, reliable processes, and our customers’ trust.
That is why quality management is built into every stage – from design transfer, manufacturing, testing and labeling & packaging through to final product release.
Our processes follow an ISO 13485-certified quality management system and meet FDA regulatory requirements. Clear responsibilities, documented workflows and defined testing and release processes help us maintain high product quality and reliable processes.
Complete traceability, thorough documentation and continuous improvement enable manufacturing that is consistent, auditable and reliable. This ensures that every product meets the defined quality requirements and is delivered in compliance with applicable standards.
Our commitment to quality goes beyond compliance. We see quality as a promise to our customers: to help bring products to market safely, reliably and efficiently.
Our quality promise
- ISO 13485-certified quality management system
- Manufacturing processes aligned with the FDA’s regulatory requirements (21 CFR Part 820)
- Full traceability
- Documented testing and release procedures
- Auditable manufacturing workflows
- Continuous improvement and risk management
- Clear responsibilities as a contract manufacturer
Certifications
Iftest Medical Manufacturing (IMM) holds the following certifications:
- ISO 13485:2016
- FDA 21 CFR Part 820
- FDA registration (pending)
Contact
We are here for you and happy to answer your questions.
Massimiliano D’Amore
Head of Operations
verkauf@iftest-medical.ch
+41 56 552 55 72
