The Tech Group understands the quality and regulatory framework required for successful scale-up or transfer of our customer’s medical devices. The Tech Group works with SGS United Kingdom as our notified body. Within the drug delivery and healthcare market, our facilities are ISO:13485 and 14001 certified and cGMP compliant. Select sites are FDA registered. The Tech Group is a Class II and Class III medical devices contract manufacturer and FDA registered drug re-packager/re-labeler at select site(s).
Key processes include:
- Customer feedback and complaint tracking
- Compliant QMS
- DMF submissions
- Qualification of Equipment, Software and process validation
- Key Performance Indicators — KPI
- Metrology – CT Scanning, CMMs, etc
- Training
- Corrective and Preventive Action (CAPAs)/documentation
Validation Infrastructure
- Quality Systems & Staff
- Dedicated Quality Engineering/Validation team(s)
- Validated Product Data Management Software
- Incoming Inspection Capability
- Extensive Validation Experience
- Molding Processes
- Assembly Processes
- Software (Control Systems ERP System, Metrology)
- West Corporate Support
- West Analytical Labs
- Clean room/micro expertise
- TPE & Rubber formulation expertise