ISO 13485 : 2016 Certified Consulting Company
We assist you in gaining the required certifications to trade in your target markets
- PMA for all Class II and III devices.
- EU Council – CE mark for all Class I, IIa, IIb, and III medical devices
- TGA – Class I, IIa, IIb and III.
- HSA – Class A, B, C and D
- Health Canada – Class I, II, III and IV
- IMDR – Class A, B, C and D