Brandwood Biomedical Newsletter July 2008

Walking the Talk - Brandwood Biomedical Achieves ISO 9001

 

We are proud to announce that we have achieved AS ISO:9001 certification for our technical, regulatory and quality consultancy services. ISO certification demonstrates our commitment to professionalism and integrity as well as to consistently provide you with the highest quality service and advice. When selecting an advisor to advise you on quality or regulatory compliance – ask the question – what level of certification or compliance have they achieved for their own operations? Copies of our certification, quality policy and quality manual are available on our website.

Human Factors

 

The US FDA has recently highlighted the contribution of human factors to adverse events in medical devices. The pertinent issue is where does the responsibility lie in ensuring correct device usage? In answer to this question, we have to look at both sides of the fence. With the rapid development of new technologies and advancement of medical devices, users are not only faced with of increasing complexity, but a greater range and diversity of devices, all of which add to the problem of incorrect usage. Medical device manufacturers need to go back to Engineering-101 and deliver device interfaces that are appropriate to the user training and skill level. So, to answer the question, both the user and manufacturer have responsibilities, but the root problem of adverse events involving human factors is often poor user interface design. Designs should also accommodate considerations for the environment where the device will be used as well as user expectations for the device. Click here to see the FDA article.

All Change at TGA...

 

Big changes are afoot at TGA as the national regulator struggles to cope with workloads while nursing a hangover from the transition to new medical device regulations. The changes will see priority for speedier assessments of new devices and a wholesale redesign of TGA’s electronic lodgement portal with a move to true notification of Class I devices. On the international front a new MOU with Canada will allow TGA to conduct manufacturer audits in support of Canadian applications. These changes promise faster market access especially for Australian manufacturers, although there remains more to be done, particularly on implementation of 3^rd party assessment. Click here for a review of the TGA changes.

Careers at Brandwood Biomedical

 

Brandwood Biomedical is growing rapidly and we are currently recruiting for new positions. If you have a regulatory, quality or product development background and are excited by the prospect of contributing to the growth of a specialist advisor working with some of the most innovative companies in the industry please contact us for a confidential chat.