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) 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 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[…]
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 to be produced according to Good Manufacturing Practices. Cosmetics Good Manufacturing Practices (GMP) is one of the pillars of the New European Regulation for Cosmetics. This regulation sets the requirements to ensure consumers’ safety. Amongst these new legal requirements, all cosmetic products circulating onto the European Market will have to be produced according to Good Manufacturing Practices; a Product Information File (PIF) is also required to demonstrate the cosmetic safety[…]
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[…]
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 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[…]
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 to be produced according to Good Manufacturing Practices. Cosmetics Good Manufacturing Practices (GMP) is one of the pillars of the New European Regulation for Cosmetics. This regulation sets the requirements to ensure consumers’ safety. Amongst these new legal requirements, all cosmetic products circulating onto the European Market will have to be produced according to Good Manufacturing Practices; a Product Information File (PIF) is also required to demonstrate the cosmetic safety[…]
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 registration, let Compliance Management Solutions act as your sponsor. About CMS: Compliance Management Solutions is an Australian based consultancy assisting organizations in TGA/MDD | ISO 9001 (Quality) | 13485 (Medical Devices) | Cosmetics GMP ISO 22716 certification, registration and consultation. Our services include: Ø Australian[…]