QUALITY & COMPLIANCE
Every implant, every lot, every time
Quality at Anatomica is not a department — it is built into every step of our manufacturing process. From incoming raw material inspection to final sterile packaging, every product passes through a documented quality control workflow before it reaches the surgeon.
ISO13485 In Progress
CDSCOMD5 Applied
54QC Tests
Quality Management System
Built-in quality at every step
- ISO 13485 quality management systemFor medical device manufacturing
- CDSCO Class C manufacturing license (MD-9)For orthopaedic implants
- Documented Standard Operating ProceduresFor every manufacturing and QC step
- Device Master File (DMF) and Plant Master File (PMF)Maintained per CDSCO Schedule IV
Material Compliance
Material traceability & standards
- Titanium implants: ASTM F136 (Ti-6Al-4V ELI) with full material traceability
- Bioabsorbable screws: ISO 10993 biocompatibility certified
- Incoming material testing: chemical composition analysis, grain structure verification
- Batch-level material certificates provided with every shipment
Manufacturing Controls
Process controls & cleanroom
- ISO Class 8 cleanroom for implant finishing and packaging
- Laser marking for permanent batch and lot traceability on every implant
- Ultrasonic cleaning and validated passivation processes
- Gamma sterilisation (validated through BRIT) for bioabsorbable products
- EO sterilisation capability for sensitive components
QC Equipment
Measurement & inspection equipment
Coordinate Measuring Machine (CMM) for dimensional verification
Profile projector for contour and hole-position inspection
Surface roughness tester for finish verification
Hardness tester for material validation
Regulatory Status
Certifications & approvals
| Certification | Scope | Status |
|---|---|---|
| CDSCO MD-9 License | Class C medical device manufacturing | In Progress |
| ISO 13485 | Quality management system | In Progress |
| Fire NOC | Facility safety compliance | Applied |
| Pollution NOC (CTE/CTO) | Environmental compliance | Applied |
| CE Marking | European market access | Planned |