Consistency across the board with state of the art technology and over 40 years of complex fabricating experience. Not only have we been recognized by customers of 40 years as the leader in quality fabrications we are also ISO 13485 & ISO 9001-2015 certified & FDA registered.
ISO 13485:2016 (medical devices) certified since 2016 which requires strict internal and external audits of medical device fabricating compliance. Some highlights include…
- Documentation for medical device files
- Production requirements for cleanliness of products
- Management and Staff Cross Training responsibilities defined and followed
- Resource Management
- Measurement, Analysis, and Improvement
- Corrective action systems
- First Article Inspections
- Clean and hygienic manufacturing areas
- Controlled manufacturing processes
- Consistency in assembly through detailed documented work instructions with frequently required QC inspections
- Customer required quality reporting
- ISO 9001:2015 certified since 1999 which requires strict internal and external audits of manufacturing production. Some highlights include…
- Customer satisfaction and quality-focused
- Safety standards
- Managed fabrication processes
- First Article Inspections
- Continuous improvement
- Controlled manufacturing processes
- Consistency in fabricating through detailed documented work instructions with frequently required QC inspections
- Customer required quality reporting
- Corrective action systems
- FDA Class 1 registered – Read more here.