As per the Australian TGA Medical Device Regulations, before someone can supply a medical device for sale in Australia they are required to make an application to include the item in the Australian Register Therapeutic Goods (ARTG). The sponsor is…
Author: gloizou
Get In Contact With CMS For All Your Medical Device Regulatory Consulting. It’s that time of year again for companies to review their Medical Device Sponsorship costs. Before you roll over for another year with your existing Sponsor get a…
by Elizabeth Gasiorowski-Denis on 26 April 2016 http://www.iso.org The records management landscape is changing. With the rise of digital content, and our increasing reliance on it, changes to the way we manage our records are inevitable. The question is how to manage these changes. Help is…
It has been a long time coming, the new Quality Management System for Medical Devices has been updated and the change is significant. http://www.iso.org/iso/home/news_index/news_archive/news.htm?refid=Ref2046 For further information contact us on: (M) +61 4 33124266 (Melbourne, Australia) (E) gloizou@compliancems.com.au
The International Organization for Standardization (ISO) has recently published a major revision to the ISO 9001 standard, the internationally-recognized standard that outlines the principles for quality management systems. The revision includes a number of important changes for organizations currently holding ISO…
As per the Australian TGA Medical Device Regulations, before someone can supply a medical device for sale in Australia they are required to make an application to include the item in the Australian Register Therapeutic Goods (ARTG). The sponsor is…
If you are a cosmetics exporter, you may have had been notified by mandated bodies that you require to comply with EC Regulation 1223/2009. What are the requirements for this new regulation? All cosmetic products exported to Europe/Asia/NZ will have…
As per the Australian TGA Medical Device Regulations, before someone can supply a medical device for sale in Australia they are required to make an application to include the item in the Australian Register Therapeutic Goods (ARTG). The sponsor is…
The International Organization for Standardization (ISO) has just published a major revision to the ISO 9001 standard, the internationally-recognized standard that outlines the principles for quality management systems. The revision includes a number of important changes for organizations currently holding…
If you are a cosmetics exporter, you may have had been notified by mandated bodies that you require to comply with EC Regulation 1223/2009. What are the requirements for this new regulation? All cosmetic products exported to Europe/Asia/NZ will have…