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

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...

DIA 2019. 23-27 June

Luis will be attending DIA 2019. The DIA 2019 Global Annual Meeting brings together thousands of innovators from around the globe. Designed to drive insights into...

A Global Approach to Clinical Evidence for Medical Devices. 13 June

Arthur Brandwood and Heyam Kalla are presenting this one day workshop at ARCS. Regulators the world over are raising the bar for medical device compliance,...

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.


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...

Japan renews its participation in MDSAP until 2020

Japan’s participation in MDSAP (Medical Device Standardized Audit Program) has been a contributing factor in the exponential update of MDSAP by multinational companies. Japan’s MHLW...

Labor’s Cancer Care Policy and the Australian Constitution

The Australian Constitution and Labor’s Cancer Care Policy. As we ever so slowly move towards the Australian Federal Election, both major parties are presenting their...

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