Standards and Certification - Page 1

Stay up to date with the latest Standards and Certification updates from the global medical device industry

Latest Standards and Certification Update

Medical device notified body ceases operation in the UK
11 July, 2019
In the event that the UK leaves the EU in a ‘no-deal’ scenario at the end...
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Using laser light to detect tumours
Wednesday, June 26, 2019 by It can be up to four weeks before patients know whether the entire tumour was removed during cancer surgery. However, a new team of scientists from Jena have developed a...

Audit finds Australian patient data vulnerable to cyber attacks
Monday, June 03, 2019 by an audit has concluded that patient data within the health system in Victoria, Australia, could easily be breached.

Canada raises regulatory fees for medical devices
Thursday, May 23, 2019 by Health Canada, the regulator for human and veterinary drugs and medical devices, has raised its fees for the regulation of devices and drugs to reflect the complexity and costs of...

RAPS Launches Europe Conference as European Regulatory Environment for Medical Products Faces Sweeping Changes
Tuesday, May 14, 2019 by The Regulatory Affairs Professionals Society (RAPS) will hold its inaugural RAPS Regulatory Conference – Europe 2019 at the Radisson Blu in Brussels, between 13 and 14 May.

Transvaginal surgical mesh banned by the FDA
Tuesday, April 23, 2019 by The US Food and Drug Administration (FDA) has ordered manufacturers of transvaginal surgical mesh to halt sales and distribution in the country following safety concerns.

FDA warning against unregulated devices for concussion
Wednesday, April 17, 2019 by Last week the FDA warned against using medical devices purported to assess head injuries, stating that only five companies are cleared to market such devices in the US and that...

Overhaul for medical devices in Australia
Tuesday, April 09, 2019 by The Australian Therapeutic Goods Administration (TGA) has just announced plans to overhaul the regulatory system for medical devices in the country to improve patient safety.

The Global Medical Device Nomenclature is now free available for all manufacturers
Thursday, April 04, 2019 by The Global Medical Device Nomenclature (GMDN), the de facto global standard for identifying the world’s millions of medical devices, has been made freely available to all...

Man-mimicking machinery for the brain
Wednesday, February 27, 2019 by A study by Harvard University have designed a probe that looks, acts and feels like a real neuron so that the brain does not identify it as a foreign object and try to attack it

Brain Tumour 'Pied Piper' Device Gains Breakthrough Status
Wednesday, February 13, 2019 by A biomedical tool that tricks aggressive brain tumours into migrating to an external container rather than in the brain has been designated a “breakthrough device” by the FDA

US researchers develop new medical devices for children
Friday, February 08, 2019 by Researchers from Stanford University and the University of California-San Francisco in the US have partnered to drive development of new medical devices for children

Call for better regulation of AI-based medical products
Friday, February 08, 2019 by Products based on artificial intelligence should be regulated like drugs, and those that are deemed unsafe should be removed from the market, according to a new report from the Academy...

The consequences of a no-deal Brexit
Tuesday, January 15, 2019 by Today MPs in the House of Commons vote on Theresa May’s deal, which could result in a no-deal scenario if it is not supported

Medical device manufacturers want more information from FDA about 3D printing
Tuesday, October 25, 2016 by Medical device manufacturers want the US Food and Drug Administration (FDA) to provide more clarity on its guidance on 3D printing.

FDA proposes medical device rule to simplify classification process
Wednesday, March 26, 2014 by The US Food and Drug Administration (FDA) is proposing to amend its regulations governing classification and reclassification of medical devices to conform to provisions in the FDA...

Applied Silicone offers comprehensive material compendia for long-term implantable silicone products
Tuesday, September 03, 2013 by Applied Silicone Corporation, a global supplier of implantable silicone material for the critical healthcare and medical device markets, announces the availability of material...

Study calls for repeal of tax
Friday, April 12, 2013 by Just a few months after the implementation of the US medical device tax, and hot on the heels of much criticism for it, a new study has concluded the policy should be repealed.

Europe split on approvals
Friday, March 29, 2013 by In March the European Commission and Parliament were reported to be in a disagreement over the possible introduction of central agency to oversee the approval of medical devices.

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