04
Custom Labelling & Packaging
05
Sterilisation & Release
Terminal sterilisation by gamma irradiation, validated per ISO 11137. Full batch records, Certificate of Analysis, and sterilisation certificates with every order.
06
Regulatory Documentation
Complete technical file including ISO 10993 biocompatibility data, sterility validation, and manufacturing records — structured to support your CDSCO, CE, or other market submissions.