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TC194XBerlin

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 TC194 was recently conducted in...
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...
HarmonisationXarticleXimage

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 changes in the US may...
SurgicalXmesh

Update on Surgical mesh medical devices

From December 1st 2018, the TGA will strengthen their premarket assessment of surgical mesh medical devices by reclassifying all these devices from Class IIb to Class III. This reclassification will...
PatientXinstructions

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 exempted) supplied in Australia. As...
PrivateXhealthXinsurance

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 a level of government subsidy...
apple-watch-3-2

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 Apple Watch. FDA cleared both...
FDA

FDA raises fees 4%

The new US financial year as always heralds increases in regulatory fees.  FDA published its 2019 fees at end of July. Fees are up around 4% across the board. The...
Watch

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...
Uncertainty

Risk vs. Benefit FDA guidance gets to grips with uncertainty

Doing risk management in an uncertain world is why regulatory affairs are as much art as science. Innovators will continue to push the envelope of the possible while regulators will...

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