Standards and Certification - Page 1
Stay up to date with the latest Standards and Certification updates from the global medical device industryLatest Standards and Certification Update
Second postponement will provide improved confidence and market...
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Amarex executes five rush COVID-19-related submissions to FDA
The submissions include an IND, IND Amendment and Compassionate Use Approval for CytoDyn’s product Leronlimab, a Compassionate Use Approval for a treatment device, and an Emergency...
Optic nerve stimulation to aid the blind
Scientists from Ecole Polytechnique Fédérale (EPFL) de Lausanne are investigating new ways to provide visual signals to the blind by directly stimulating the optic nerve
Medical device notified body ceases operation in the UK
In the event that the UK leaves the EU in a ‘no-deal’ scenario at the end of October this year, UK Notified Bodies will lose their designation under the Medical Device Directives
Using laser light to detect tumours
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Applied Silicone Corporation, a global supplier of implantable silicone material for the critical healthcare and medical device markets, announces the availability of material...
