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.


TC194 Wrap Up 2018

TC194 – The Big Wrap The ISO Technical Committee 194 is responsible for the biological and clinical evaluation of medical devices. The Annual meeting of...

Halfway there? Will the MDR/IVDR train arrive on time – and what about Brexit?

As the implementation journey for the EU MDR/IVDR passes the halfway point, we provide an update to the current state of play and the impact...

Harmonization in Plain Sight. Are FDA and CE Substantially Equivalent?

Medical device harmonization continues to struggle, with substantial differences between FDA and Europe continuing to be an obstacle. However, current changes in Europe and proposed...

Events & Webinars

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

MedTech’s Got Talent | Pre-Accelerator Program. 10-14 December

Australia's First National Medtech Accelerator! Terrance Thiel will be presenting "Regulatory Pathway Insights" on the 10th of December 2018 12:45-2:45pm. Find out details and register...

J.P. Morgan Healthcare Conference. 7-10 January.

Luis will be attending the annual J.P. Morgan Healthcare Conference is the largest and most informative healthcare investment symposium in the industry, bringing together industry...

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...

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