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.


TGA Introduces Patient Implant Cards…and the dates are approaching fast!

In October 2017, the Australian government approved regulations introducing requirements for manufacturers to provide consumer information with all new permanently implantable devices (other than those...

Ongoing Reform of Private Health Insurance – what it means for Medical Devices

Private Health Insurance (PHI) in Australia has been under the microscope for several years. With nearly half of all Australians choosing to purchase PHI, and...

Not so fast. What really happened with FDA’s clearance of the Apple Watch ECG

There’s lots of noise about the very rapid de novo clearances for Apple’s “Irregular Rhythm Notification Feature” (DEN 180042) and ECG App (DEN180044) for the...

Events & Webinars

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

A Global Approach to Clinical Evidence for Medical Devices. 12 November

Regulators the world over are raising the bar for medical device compliance, and no more so than in Clinical Evidence requirements. Every device and IVD...

LIVE WEBINAR: Why MDSAP opens a world of opportunity. 22 November

MDSAP is taking off, and don't believe the scare stories. It's a manageable extension of ISO 13485 which will smooth pathways to a growing number...

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