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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 in. Up until now, there was no means of identifying medical substances on a global basis. This led to numerous challenges when adverse reactions to medicinal products were reported in one country and had to be interpreted by others. Greater co-ordination among drug regulatory authorities and increased transparency in reporting suspected adverse drug reactions was[…]

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

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 can save you too. Speak to one of our leading specialists today for your hassle free transfer. Compliance Management Solutions Melbourne, Australia E: [email protected] | M: +61 433 124 266 | W: https://compliancems.com.au

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 are an overseas manufacturer of medical devices and you require Australian ARTG entry, let Compliance Management Solutions act as your sponsor. We aim to provide our customers with the highest level of service with an efficient and cost effective approach. About CMS: CMS is a service provider for the following: Cosmetics: Cosmetics GMP ISO 22716 implementation[…]

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 can save you too. Speak to one of our leading specialists today for your hassle free transfer.  

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 account the big picture. This involves understanding the context you operate in, the nature of the business you do and the risks and requirements associated with that business. The good news is that it’s possible to design systems and apply rules so that the records are made and kept properly – whether they are data,[…]

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) [email protected]

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 system. This ISO 9001:2015 version follows the new high-level structure and comprises ten sections: Scope Normative references Terms and definitions Context of the organisation Leadership Planning (including Risk Analysis) Support Operation Performance evaluation Improvement How can you prepare? Organisations that have established management systems should familiarise themselves with the changes and subsequently upgrade their management[…]

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 are an overseas manufacturer of medical devices and you require Australian ARTG entry, let Compliance Management Solutions act as your sponsor. We aim to provide our customers with the highest level of service with an efficient and cost effective approach. About CMS: CMS is a service provider for the following: Cosmetics: Cosmetics GMP ISO 22716 implementation[…]