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.

Events & Webinars

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

MDCTP – Regulatory Workshop. 29 April

Presented by Arthur Brandwood, this 1-day workshop at Cicada Innovations will take a deep dive into the global regulatory requirements for medical devices and diagnostics....

AusMedTech: Pre-conference workshop – Regulatory affairs, Health economics and reimbursement workshop

Join Arthur Brandwood and Sarah Griffin when they present the pre-conference workshop at AusMedTech on 13 May. This is a full day event providing attendees...

Bio 2019. 3-6 June

Join Luis in Philadelphia, PA, June 3-6, 2019 as more than 16,000 attendees from around the globe gather for unparalleled partnering, education, networking, and to...

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.

Team work

All Together Now – FDA Builds Devices Super Office

The biggest difference between the FDA way and the rest of the world is the separation of activities into device assessment, which comes first and...
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Europe’s pragmatic approach to clinical evidence for legacy devices – or why the devil is always in the detail…

Regulatory affairs demand attention to detail. So when the European Medical Devices Coordination Group released document MDCG 2019-3 - Interpretation of Article 54(2)b we regulatory...
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Australian Regulator Prepares for the Brexit Fallout

Following our earlier article Fog in the Channel: a European Medtech Perspective on Brexit where we outlined the need for the EU and UK to...

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