In October 2019, we announced that we have been ISO 13485-certified by BSI.
Since then, we have continued developing and improving on our quality management system in order to maintain consistently high quality safe and effective products and services for our clients in the medical devices segment.
Today, we are thrilled to share that we have passed this year’s recertification audit to maintain our ISO 13485:2016 certification status.
What is ISO 13485? It is an internationally recognised standard for a Quality Management System (QMS) where an organisation needs to demonstrate its ability to supply medical devices and related services that consistently meet customer and regulatory requirements. All ISO standards are reviewed and updated every five years. This global standard is mandatory in some countries.
This recertification provides Aesthetic Bureau another 3 years of ISO 13485 registration, subject to continuing surveillance audits carried out by BSI.
By using ISO 13485 standards to implement our quality management system, we can ensure that we have a world-class system for meeting the requirements of customers and legislators for our medical devices.
This follows our years of commitment to making sure our quality processes are continuously improving.
As Australia’s trusted leader in medical aesthetic technology, Aesthetic Bureau is committed to evidence-based solutions, transparency, and the highest regulatory standards. Here, we address the confusion surrounding Nogier frequencies in LED photobiomodulation. Our aim is to help you make informed decisions for your clinic and clients. Understanding the Nogier
RF Microneedling: Creates microdermal wounds with mechanical and heat injury at varying depths of the skin. Causes micro-injuries that do not stimulate ablation or coagulation. The addition of RF heat to microneedling can stimulate fibroblast cells and collagen remodelling like fractional RF, but due to lack of volumetric tissue ablation
Red light therapy involves exposure to specific wavelengths of LED light (red and near infrared light) to the skin for therapeutic benefit. These two wavelengths of light combined have been shown to create the biggest biological response in the body compared to other wavelengths. Because red light releases ATP into
TL;DR Red light therapy (RLT), also known as photobiomodulation (PBM), is booming across Australian clinics, with demand projected to rise 6.8% annually through 2027. The critical distinction? Medical-grade devices specify therapeutic energy output and comply with strict TGA standards, while consumer-grade devices often rely on high input wattage claims but