Quality throughout the entire
value chain
You can rely on Schuler Medical
Quality and safety are the top priorities at Schuler Medical.
We achieve precision through a consistently implemented, ISO 13485-certified quality and process management tailored to the requirements of implant manufacturing.
Our qualified employees ensure that all products and processes meet the defined requirements—not just out of regulatory necessity, but out of responsibility toward our partners and the end users.
Schuler Medical stands for verifiable quality—documented, validated, and fully traceable at all times.
This is how we ensure the quality of our implant manufacturing:
Zero-defect strategy
- From material receipt to the fully inspected implant
- Quality assurance as an integral part of all manufacturing and inspection processes
- Use of certified materials from qualified and approved suppliers
- Continuous improvement through training, audits, and data-based SPC analyses
State-of-the-art measurement technology
- In-process measurement technology and 3D measurement systems for continuous monitoring of critical features
- Real-time SPC monitoring
- Surface inspection to ensure clean and biocompatible surfaces
Labeling and traceability
- Laser marking for unique identification and complete traceability
- Documented FDA-compliant labeling
Cleanroom and assembly
- Assembly under controlled cleanroom conditions
- Validated processes for sterile and safe implants
We would be happy to discuss our quality assurance processes with you.
Regulatory compliance for your approval procedures
Our processes are ISO 13485 certified and meet the requirements of FDA 21 CFR Part 820. With seamless documentation and full traceability, we support smooth audits and regulatory inspections.
- ISO 13485-certified quality management system
- Processes aligned with FDA 21 CFR Part 820 requirements
- Structured process validation with automated data capture
- Support for audits and regulatory approval processes
- Digital manufacturing management systems for process control and monitoring
Tip: We actively support you in regulatory approval processes.
Schuler Medical: a division of Schuler Präzisionstechnik
As the medical technology division of Schuler Präzisionstechnik, you benefit from decades of experience in precision manufacturing, established processes, and a corporate culture focused on reliability and long-term partnerships.
