Process
- Reusable medical devices, reprocessing validation as per EU MDR 2017/745- Annex I (GSPR 10, 11 & 23), Annex II Technical Documentation
- FDA Guidance: Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling US FDA (510K)- Premarket submission requirements (510(k), PMA, De Novo, HDE, IDE) March 2015, with Appendix E updated in June 2017
| Validation Activity | Applicable Standard |
|---|---|
| Cleaning Validation | ISO 15883 series, AAMI TIR30, AAMI TIR12 |
| Moist Heat Sterilization | ISO 17665-1 |
| EO Sterilization | ISO 11135 |
| Vaporized Hydrogen Peroxide (VH₂O₂) | ISO 22441 |
| Washer-disinfector | ISO 15883 series |
| Packaging | ISO 11607-1 & ISO 11607-2 |
| Biological Evaluation After Reprocessing | ISO 10993-1 |
| Microbiological Methods | ISO 11737-1 & ISO 11737-2 |
| Protein Detection | ISO 15883 guidance / validated analytical methods |
| Endotoxin | USP <85> / Ph. Eur. 2.6.14 |
| Pyrogen | ISO 10993-11 (as applicable) |
Our Facility Equipped with
EU-MDR/21CFR compliance Washer Disinfector and Steam Autoclave for following Reprocessing Medical devices
- Surgical instruments
- Endoscopes
- Orthopaedic instruments
- Powered surgical devices
- Laparoscopic instruments
- Dental instruments
- Ophthalmic surgical instruments
- Robotic surgical accessories
- Transport Validation with ISTA Certification and Post Simulation validation for all Medical Devices and Health care Products
- Sterilization validation and Documentation support for (EO, Gamma, Steam, Ultrasonic Cleaning and Plasma Sterilization)
- Clean room validation and Qualification & Consultation
