Regulatory Affairs

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  

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.

ORA innovations boasts over 30 years of combined experience in Quality Management Systems, Compliance, Project Engineering, Product Development, Auditing, Training, New Product Introduction, Documentation and Manufacturing for diverse industries from Electronic Equipment, to Medical Devices and Pharmaceuticals.

With a wealth of experience in Implementing, Auditing and Managing Quality Management Systems ORA innovations has led a number of Medical Devices Companies to achieve their certification to ISO13485, CE Mark their products and others to ISO 9001.

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