Luis Jimenez

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Software as Medical Devices (SaMD) Growing Regulatory Trends and Opportunities for Innovators

With SaMD attracting larger players and devices like the Apple Watch, FDA and regulators globally, are developing frameworks for regulating these more efficiently. On Sept 11th, 2018 Apple obtained FDA...
Brandwood Biomedical global experts medical devices regulatory affairs consulting medical devices IVDs Brandwood Biomedical Global Expertise in Medical Device Regulatory Compliance Australia China Taiwan Hong Kong Europe New Zealand United States

TGA issues international collaboration guidelines for review of pharma applications

New guidelines for collaboration with overseas regulators were issued on June 15th 2018 by the TGA. Australia’s Therapeutic Good Administration (TGA) has issued a guidance for a framework to enable...

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