Perform Regulatory Path Analysis.

Facilitate the Compliance of your Product to the Regulatory Requirements worldwide:

• In Australia — TG Regulations

• In EU — CE Mark, MDD93/42/EEC, IVD 98/79/EEC, AIMD 90/385/EEC, EU MDs Regulations

• In the US — FDA QSR, 510(k), PMA

• In Canada — CMDR/CMDCAS

• In Singapore – HAS

• In Japan — PMDA

• In China — sFDA

• Other Countries Regulations

 

Advise on & Help prepare documentation

• Product Classification

• Technical File preparation

• Essential Requirements – TGA

• Essential Principals – EU, Canada, others

• Risk Management / Analysis - EN ISO 14971

• Human factor engineering/ Usability Study - EN ISO 62366  

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Regulatory services

• CE Mark Application

• UL and CSA Mark Applications

• We can represent your company with the TGA and perform all required services from submissions to registrations and inclusion of your product on the ARTG.