Jean Boudaud

Changes ahead

Proposed delayed commencement of certain Medical Device Regulatory Changes

During recent months, the world has been focusing on their emergency response to the Covid-19 pandemic, while Manufacturers were still expected to implement transitional arrangements to the new Medical Device...

510k Modernization in progress

In our live webinar of January 2019 “Making American Guidance Understandable Again”, we highlighted a range of FDA initiatives towards a modernization of the US Medical Device Regulations. During that...
Hong Kong

Hong Kong Regulatory Processes Overview

Regulatory System Medical Device regulations and import in Hong Kong operates under its own framework, controlled by the Medical Device Control Office (MDCO), a division of the Department of Health...

Update on Surgical mesh medical devices

From December 1st 2018, the TGA will strengthen their premarket assessment of surgical mesh medical devices by reclassifying all these devices from Class IIb to Class III. This reclassification will...
Brandwood Biomedical global experts medical devices regulatory affairs consulting medical devices IVDs Brandwood Biomedical Global Expertise in Medical Device Regulatory Compliance Australia China Taiwan Hong Kong Europe New Zealand United States

Marketing in a regulated market

Last month, the Brandwood Biomedical team had the privilege of presenting at the ARCS conference here in Sydney. This gave me an opportunity to speak about one of my dearest...
Is your Audit Program Adding Value Brandwood Biomedical

Is your Audit Program Adding Value?

Audits are all too often seen as a necessary evil - the means to achievement of that all important certification.  But well constructed programs of internal and vendor audits can...
MDSAP RecapBrandwood Biomedical


Introduction About a year ago, one of our blogs highlighted some of the MDSAP program intents and benefits. Having gained visibility on its implementation, we would like to provide an...
Demystifying Process Validation Brandwood Biomedical

Demystifying Process Validation

Process validation, in the Medical Device and Pharmaceutical industry is a vitally important component of your Quality Management System. While reasonably straightforward in principle, poor implementation may lead to uncertainty...


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