We deliver consistency across the board with state-of-the-art technology and over 45 years of complex fabrication experience. Recognized by long-term customers as a leader in quality fabrications, we are ISO 13485:2016 and ISO 9001:2015 certified and FDA registered..
ISO 13485:2016 (medical devices) 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 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.