Accreditations
Australian Aesthetic Devices Pty Ltd trading as Aesthetic Bureau are proud to announce that we have certification of the latest standards of ISO 13485:2016 through accreditation with British Standards Institution (BSI).
This indicates we have met all requirements for a comprehensive Quality Management System for the design and manufacture of medical devices for regulatory purposes.
As part of our accreditation, we are required to undergo stringent auditing every 12 months to ensure we continue to meet the highest quality standards recognised worldwide for medical device manufacturing.
In addition, we have achieved CE Marking (under Medical Devices Directive 93/42/EEC) for the manufacture of multi-modality skin surface treatment systems and photobiomodulation systems (i.e. our IPL and LED therapy systems).
All medical device manufacturers marketing their systems in the EU must achieve compliance with the required conformity assessments of this medical directive.
This process includes performance of a risk/benefit analysis regarding the devices, reducing risks to the minimum, adopting adequate safety measures, and fully informing users of any remaining risk.
We use this CE Marking for our Therapeutic Goods Administration (TGA) conformity assessment for inclusion of our medical devices in the Australian Therapeutic Goods Administration (ARTG).
While CE Marking is a European process, regulations in Australia are aligned very closely with Europe. The TGA recognises CE certification for compliance of medical devices with TGA regulatory requirements.
