Quality is the substrate. Not the output.
Our quality management system is built on the principle that the only acceptable level of defect in a Class III implant is zero. Every step of the patient-data-to-implant pipeline is validated, traceable, and auditable.
Built on the strongest medical device QMS framework.
Six disciplines. One promise.
1. Document control
Every SOP, work instruction, and design document is version-controlled, reviewed, approved, and distributed under formal change control.
2. Process validation
Process validation per ASTM F3301. FEA per ASTM F382. Packaging per ISO 11607. Sterilisation per ISO 11135. All methods qualified, all equipment calibrated.
3. 100% inspection
Every implant is CMM-inspected. Every implant is CT-scanned against its design STL. Statistical process control on every machine, every shift, every lot.
4. Risk management
Full ISO 14971 risk management. FMEA updated with each design change. Benefit-risk continuously evaluated against post-market data.
5. Post-market surveillance
Active post-market surveillance. Every complaint investigated within 24 hours. CAPA loop closed with quantified effectiveness checks. Field safety corrective actions per MDR Article 87.
6. Traceability
Every implant is traceable to its patient dataset, powder lot, build cycle, post-processing cell, inspector, and shipment. Full genealogy for the entire life of the product.
What our quality system covers.
Design controls
- Design & development planning (per ISO 13485 7.3)
- Design input / output traceability
- Design review, verification, validation
- Design transfer to manufacturing
- Design change control
- Design history file (DHF) per implant
Production controls
- Process validation (IQ / OQ / PQ)
- Statistical process control (SPC)
- 100% CMM inspection
- In-house CT conformity check
- Lot genealogy & traceability
- Environmental monitoring (cleanroom)
Supplier controls
- Supplier qualification & audits
- Incoming inspection on critical materials
- Powder lot genealogy & testing
- Long-term agreements with key suppliers
- Change notification agreements
CAPA & continuous improvement
- CAPA system per ISO 13485 8.5.2
- Root cause analysis (5-Why, Fishbone)
- Effectiveness verification
- Management review (monthly)
- Quality objectives & KPIs
- Customer feedback integration
What we measure. What we deliver.
Want a tour of the quality system?
Qualified clinical and commercial partners can request a quality system overview and a facility tour.