Quality
Quality at Gebrüder Renggli AG isn’t just a promise – it’s what we practice.
At Every Step of the Process
Quality: A Lived Standard and a Binding Commitment
We embed quality into every step of our value chain at Gebrüder Renggli. As an ISO 13485:2016 certified and FDA-registered manufacturing partner, we meet the highest standards for traceability, documentation, and process reliability. Our cleanroom production, validated procedures, and systematic quality assurance ensure not just compliance – but confidence. Behind this stand experienced professionals, modern infrastructure, and a culture of responsibility – delivering medical-grade plastic solutions you can rely on.
Made in Switzerland
Our production takes place entirely in Switzerland – defined by the highest standards of precision, care, and sustainable manufacturing processes. The combination of specialized expertise and modern infrastructure enables us to produce complex plastic solutions at the highest level. For us, “Made in Switzerland” is not a marketing phrase – it’s a daily commitment to our customers and the industry.
Our Certifications
Gebrüder Renggli AG has been committed to a consistent, process-driven quality strategy since 1995.
ISO 13485:2016
Since 1995, we have been a certified company – initially according to ISO 9001, and since 2005 according to ISO 13485:2016. Our regular audits and re-certifications underline our consistent commitment to the highest quality and process standards.
Show Certificate ISO 13485 (March 2023)
FDA Contract Manufacturer
As an FDA-registered contract manufacturer, we meet the strictest regulatory requirements. This registration underscores our expertise in delivering safe and high-quality products for the international medical technology market.
Risk Management based on ISO 14971
Integrated CAPA and Change Management
Qualification of Tools, Systems and Equipment
Clean room monitoring according to ISO 14644-1 Class 7
In-house Measurement and Testing Methods
Optical Inspection on the Microscope
Measuring Microscopes
3D Touch Probe
Tensile and Compression Testers
Moisture Analysis
