Quality
Swiss precision, trusted quality
At Weidmann Medical, quality is at the core of everything we do. Certified to ISO 13485 and FDA-listed, we deliver consistent, compliant solutions. From complex new developments to transfer tooling, our experienced teams and rigorous quality systems ensure reliability, safety, and performance – meeting the high expectations of the medical and pharmaceutical industries worldwide.
Excellence in
every interaction
At Weidmann Medical, quality is integral to every customer interaction. Our ISO 13485-certified quality management system and our FDA-listed production sites ensure that we meet and exceed the stringent requirements of the medical and pharmaceutical industries. We prioritize clear communication, proactive support, and collaborative problem-solving to deliver reliable, compliant solutions tailored to each client’s needs.
Production
and processes
Our commitment to quality extends through every stage of production. Operating in ISO Class 7 and 8 cleanroom environments, we implement continuous particle and microbiological monitoring to maintain product integrity. Advanced process controls, including 100% in-line vision systems and statistical process control (SPC), ensure consistent quality. Each batch undergoes a stringent lot approval process, accompanied by comprehensive Certificates of Analysis, guaranteeing traceability and compliance.
Quality management
We practice professional management processes and utilize a comprehensive Quality Management System:
- Certified ISO 13485
- FDA-listed to CFR820 standards
- Project- and manufacturing processes to cGMP-standards
- Supply risk mitigation and emergency planning
- Fulfillment of SHE-, ROHS-, and REACH-standards
- Risk management according to ISO 14971
- Integrated CAPA- and change control-systems
- DQ, IQ, OQ, PQ qualifications and validations
- Software validation to FDA, Part 11 standards
- Design history files, device master records
