Swiss Quality, Practiced World-Wide

Weidmann Medical Technology has built several production sites in Switzerland.  Swiss quality also in the industrialization and qualification phases. If desired, the validated production lines, together with our know-how and specific competences, can be transferred to the appropriate production site.

Service

Our services stand for efficiency and reliability. Our customers count upon:

  • A motivated, involved team
  • Fast reaction times and transparent communications
  • Flexibility and creativity in problem-solving
  • A communications partner for all situations

Production And Processes

  • Continuous particle monitoring in clean-room classes to ISO Class 5
  • Microbiological monitoring
  • RNase/DNase- and pyrogen-free production
  • Process control via 100% vision- and SPC-systems
  • Cpk-based lot approvals with CoA packet
  • UDI labeling
Qualität

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- und REACH-Standards
  • Risk Management according 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