Brandwood Biomedical Newsletter September 2009
Wednesday, September 16, 2009 at 3:07PM AusBiotech Conference 2009
The 2009 AusBiotech Conference is the premier event for the Asia Pacific biotechnology and life sciences industry. Brandwood Biomedical is proud to be supporting the event which will be held at the Melbourne Convention and Exhibition Centre from 27th-30th October.
The conference will feature a number of sessions and presentations with themes ranging from medical technology to investment and business, providing attendees with a great opportunity to learn about the latest technological developments and the new challenges they bring.
Brandwood Biomedical Managing Director, Arthur Brandwood will be speaking in the session titled “In Vitro Diagnostics: New Technologies, New Markets, New Regulations, New Risks?”, to be held on Thursday 29th October from 2:00 to 3:30 pm. A full schedule for the conference can be found here.
Want to talk? We’ll be at the conference exhibition under the stand “Constellation BioConsulting”, where we would be delighted to meet you – or please contact us if you wish to arrange a specific meeting. Please feel free to arrange a specific time to meet at the conference via the biopartnering.com website: www.biopartnering.com
Laboratory Managers Conference 2009
Brandwood Biomedical is a proud supporter of the 2009 Laboratory Manager Conference. The conference will be held at the Sebel and Citigate Hotel in Melbourne from November 9th – 11th, and will feature sessions related to various aspects of laboratory management including analytical testing, education, research, regulation and quality control. The event will provide attendees with a chance to learn about new strategies and tools used in laboratory management, and also provide the opportunity to build networks with a range of leading specialists in laboratory, research, scientific and technical management. Click here to learn more.
AusMedTech 09
AusMedtech09 was a great success. In a year where conferences have struggled with numbers, attendance hit a record high. Run on the 14th and 15th of June, delegates were treated to two days of world-class speakers and workshops focused on the overall message of the conference: creating value and mapping out the global path to success. It was clear from the excitement and talk in the room that Australia is well equipped to position themselves on the world stage as medical device and diagnostic innovators. This theme was re-iterated by the Hon Jodi Mckay, Minister for Science and Medical Research, who made an address at the conference welcome.
The conference dinner, sponsored by Brandwood Biomedical, was a very successful occasion allowing delegates time to relax and network with colleagues and friends from the industry. Thank you to all the organizers, speakers and delegates on a spectacular conference and we look forward to AusMedTech in 2010.
ARCS 09 follow up
The ARCS 18th Annual Scientific Congress was held on the 1st – 3rd June 2009 at the Sydney Convention and Exhibition Centre. Attendance was up 5% on last year and boasted a large range of sessions covering the latest developments in the therapeutic development arena. This was the first time that Brandwood Biomedical attended this congress and it was a very worthy event.
Cost Effective Quality with Q-Pulse
Inefficient and time-consuming processes! Poor employee buy-in! Missed opportunities to trend and capture all the data! These are all symptoms of a disjointed quality system that could benefit from an integrated compliance management system.
Brandwood Biomedical is Australia’s only accredited supplier of Q-Pulse by Gael software in the Life Sciences sector. As a testament to our industry reputation and knowledge of quality management systems, we have recently forged an exclusive (Value added reseller) partnership with Gael, the suppliers of Q Pulse in the life science sector.We believe that Q–Pulse is one of the most cost effective solutions available. Q-Pulse is a scalable and easy to use system that covers key quality and regulatory functions such as Auditing, Document Control and Corrective actions. It is also fully compliant with US “Part 11” requirements.
We can configure an implementation that’s right for you. Head to the “Our Services” page for more details on Q-Pulse or contact us if you would like to know more.
Update on Imminent European MDD Changes
In May the EC released an interpretative document of Directive 2007/47/EC, providing clarification on certain issues within the Directive. The interpretive document can be found here, and the Directive here.
In September 2007, the European Commission released Directive 2007/47/EC, a document which amended both the Medical Devices Directive MDD 93/42/EEC and the Active Implantable Medical Devices Directive AIMDD 90/385/EEC. The amendments are to apply from 21st March 2010. To refresh your memory, the major changes made by Directive 2007/47/EC can be viewed in our March 2008 Newsletter, under the heading European MDD Changes. The most significant change would undoubtedly be the requirement for clinical evidence to be documented in the Technical File for all medical devices, regardless of class.
The interpretative document acts as a guidance document to address questions relating to the implementation of Directive 2007/47/EC. The document states that medical devices placed on the market or put into service after March 21st 2010 would need to comply with the new requirements made in Directive 2007/47/EC. As no transitional provisions have been given, we recommend implementing the amendments much earlier than March 21st 2010. Products brought to the market or put into service before this date may continue to be marketed, however the manufacturer must document that their Declaration of Conformity states conformance with the amendments.
The document also states that certification for EC marking will no longer be unlimited as of 21st March 2010, but will have a maximum validity of 5 years. Devices to be placed on the market or put into service after 21st March 2010 with unlimited certificates require to be reissued with limited validity certification before the 21st March. Those devices already on the market or put into service do not require reissuing of certificates and may use the unlimited validity CE marking certification.
Need assistance with implementing the amendments? Contact us to talk.
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