Compliance with confidence

Join the team that's served the industry for 20 years. With Brandwood Biomedical, you're getting a regulatory partner with the expertise and a flexible, strategic approach that aligns with your objective - market access.

Global Medical Device and IVD Regulatory Services

Commercialising a new medical device or IVD is a convoluted process, only made more so by differing requirements across location, usage and level of risk. We can help you understand your requirements and guide you through the process to ensure you meet the exacting criteria for global approval.

Not sure of your next step?

We can help you break through the red tape with the right strategies and submission guidelines to open your device to the world.

Keep up to date

Read about the latest developments and case studies from across the globe.

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On Chemical Analysis – the truth

As I mentioned in my last article, some very interesting information came into the light at the ISO/TC 194 meeting in Berlin last year concerning...

New Zealand WANDers towards increased device regulation

If you are WANDering about the title of this blog, yes, it’s a dreadful pun I know – but it’s that time of year. New...
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MDSAP Stakeholder Update (FDA, TGA, Health Canada, PMDA, ANVISA)

On Dec 5th, 2018 the representatives from US FDA, Brazil’s Anvisa, Japan’s PMDA, Australia’s TGA, and Health Canada met in Washington, DC with stakeholders from...

Events & Webinars

Find out where we'll be and register for our upcoming webinars

Med Tech Monday. 28 January.

Brandwood Biomedical is a proud sponsor of the 2019 Med Tech Monday. Med Tech Monday, a one-day medical device conference, will provide Orange County in...

LIVE WEBINAR: Making American Guidance Understandable Again: How FDA’s new enthusiasm for harmonization brings opportunity for international firms. 17 January

FDA has announced broad reaching initiatives to update the 510(k) program and leverage international practices and requirements. This brings real opportunities for international firms to...

Why Australia for medical innovations? 31 January

Grant Bennett will be speaking at this event in January 2019. Australia is a global leader in medical technologies and offers ranging from discover through...

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