• gloizou
• Jul, 07, 2016
• Uncategorized
• Comments Off on How standards instil trust in the latest ISOfocus

by Elizabeth Gasiorowski-Denis on 6 July 2016 With trust, businesses and consumers embark on a lifelong journey towards solutions that will meet their mutual expectations – productivity, performance and quality of life. In theISOfocus magazine (July/August 2016), you’ll learn about how standards help bridge this relationship, instilling confidence on both sides. In her opening comment, Fadilah Baharin, CEO […]

• gloizou
• Jul, 01, 2016
• Uncategorized
• Comments Off on Buying Medicines & Medical Devices Online

• gloizou
• Jun, 23, 2016
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• Comments Off on Pharma sector gets new ISO tool for drug identification

by Elisabeth Gasiorowski-Denis on 23 June 2016 http://www.iso.org/iso/home/news_index/news_archive/news.htm?refid=Ref2092 With hundreds of thousands of prescription drugs on the market, the pharmaceutical sector faces an increasingly complex and risky challenge. Rapid growth in the number of available medications may be contributing to increased uncertainties. That is where the new ISO IDMP (IDentification of Medicinal Products) series comes […]

• gloizou
• Jun, 20, 2016
• Uncategorized
• Comments Off on ISO 50001 on energy management is under revision

by Sandrine Tranchard on 14 June 2016 http://www.iso.org/iso/home/news_index/news_archive/news.htm?refid=Ref2091

• gloizou
• Jun, 16, 2016
• Uncategorized
• Comments Off on TGA Australian Sponsorship for Medical Devices 2016-2017 Due Soon!

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 quote from us! We have saved our clients thousands, let us see how much we […]

• gloizou
• Jun, 16, 2016
• Uncategorized
• Comments Off on TGA Australian Medical Device Sponsorship

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 person or company responsible for the importation of therapeutic goods into Australia. If you […]

• gloizou
• May, 18, 2016
• Uncategorized
• Comments Off on Australian Sponsorship for Medical Devices 2016-2017 Due Soon!

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 quote from us! We have saved our clients thousands, let us see how much we […]

• gloizou
• May, 18, 2016
• Uncategorized
• Comments Off on Records management in the digital age

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 on its way with the newly publishedISO 15489-1. Your records management strategy has to take into […]

• gloizou
• Feb, 29, 2016
• Uncategorized
• Comments Off on New Revision to ISO 13485

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

• gloizou
• Feb, 25, 2016
• Uncategorized
• Comments Off on ISO 9001:2015 Quality Management System

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 9001 certification, as well as those contemplating the development and implementation of a quality management […]