We are in the process of obtaining international certification for these chambers so they are cleared as approved medical devices within our regions.
ISO 13485:2003 – Quality Management System for Medical Devices
ISO 13485:2003 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.
ISO 9001:2008 – Generic Quality Management System
ISO 9001:2008 specifies requirements for a quality management system where an organisation needs to demonstrate its ability to consistently provide product that meets customer and applicable statutory and regulatory requirements, and aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.
CE MDD 93/42/EEC
The Medical Device Directive (Council Directive 93/42/EEC) is intended to harmonise the laws relating to medical devices within the European Union. The MD Directive is a ‘New Approach’ Directive and consequently in order for a manufacturer to legally place a medical device on the European market the requirements of the MD Directive have to be met. Manufacturers’ products meeting ‘harmonised standards’ have a presumption of conformity to the Directive. Products conforming with the MD Directive must have a CE mark applied.
This Standard is a ‘parent’ document which sets out basic requirements and good practice for the design, materials, manufacture, examination, testing, installation, conformity assessment, commissioning, operation, inspection, maintenance, repair, alteration and disposal of pressure equipment (boilers, pressure vessels and pressure piping) but excluding gas cylinders, blast furnaces, pipelines, fire extinguishers, storage tanks to name a few.
Australian Register of Therapeutic Goods
The Therapeutic Goods Administration (TGA) is part of the Australian Government Department of Health, and is responsible for regulating therapeutic goods including prescription medicines, vaccines, sunscreens, vitamins and minerals, medical devices, blood and blood products. Almost any product for which therapeutic claims are made must be entered in the Australian Register of Therapeutic Goods (ARTG) before it can be supplied in Australia. Healing Chambers are working to demonstrate compliance of our chambers to the Australian Standards and have them listed on the Australian Register of Therapeutic Goods.