- Pre-production support, pFMEA, control plans, manufacturing process instructions, etc.
- Quality manuals
- Medical market process verification
- IQ, OQ and PQ for processes and equipment
- pFMEA development
- FDA Title 21 Part 820 FDA compliance
- Content for design history files and device master records – materials and process
- Live large screen SPC and CpK metrics in manufacturing areas
- Certified operator training with records
- S 2020 ESD compliance
Quality is evident throughout the supply chain
- Automated MRP and production control system
- Consigned and turnkey materials
- Full traceability, build records and C of C’s
- On demand inventory and cycle counts
- AVL adherence
- Vendor audits and qualifications
- IQC of all materials
- Alarm monitored freezers
- Nitrogen storage cabinets
- Expiration date tracking
Quality is assured by a certified supplier
