Jean Boudaud

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Update on Notified Bodies designation under MDR / IVDR

The implementation of the new European MDR (2017/745), now in place since May 2021 and IVDR (2017/746) less than a year away, has proven to be a very challenging task...
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Transition plan from Custom device to Patient-matched

In our Blog of June 2020, we communicated on the delays relating to the implementation dates of the December 2019 amendment of the Therapeutic Goods (Medical Devices) Regulations 2002. The...
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The Medical Devices Regulation (EU) 2017/745 and In Vitro Diagnostic Regulation (EU) 2017/746 include use, maintenance and management of a European databank on medical devices (EUDAMED). The database consists of...
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MD Regulatory transition under Brexit

With the UK having exited the EU in February 2020 (Brexit), manufacturers of medical devices and IVDs need to ensure they have plans in place to comply with the UK...
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...


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