Luis Jimenez

Train-derailing

And so starts the MDR/Brexit fallout… First LRQA and now QS Zurich fall by the wayside

Breaking News: As of June 13th, Lloyds Register Quality Assurance (LRQA) withdrew from MDD and IVDD services (see the announcement here). It's official, the first notified body based in UK...
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TGA will no longer send “friendly reminders” for Annual Reports.

In a communication on May 15th, TGA announced they will no longer be providing courtesy formal correspondence requesting annual reports from Australian Sponsors, and failing to provide annual reports may...
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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 and PMDA has been opting...
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The commercialization continuum: beyond product registrations

Your product is approved, now what? This is a question that can bring a painful realization to medical technology manufacturers and suppliers eagerly entering a new market. The appropriate preparation...
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MDSAP Stakeholder Update (FDA, TGA, Health Canada, PMDA, ANVISA)

On Dec 5th, 2018 the representatives from US FDA, Brazil’s Anvisa, Japan’s PMDA, Australia’s TGA, and Health Canada met in Washington, DC with stakeholders from the medical device industry to...
TrainXstation

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 on our industry. Many, if...
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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...
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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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