The FDA is Recommending Transition to New Duodenoscopes

USA – The FDA is Recommending Transition to New Duodenoscopes

Duodenoscopes play a vital role in the assessment and treatment of diseases and conditions of the pancreas and bile ducts, and are used in...
US FDA recognizes latest edition of ISO 14971 as medical device consensus standard

USA – US FDA recognizes latest edition of ISO 14971 as medical device consensus...

The US Food and Drug Administration has granted Recognized Consensus Standard status to the third edition of the ISO 14071 risk management standard for...
FDA Finalizes Guidance on Annual Reports for Approved PMAs

USA – FDA Finalizes Guidance on Annual Reports for Approved PMAs

The US Food and Drug Administration (FDA) last month altered and finalized a 2014 draft guidance explaining what information needs to be provided in...
CDRH Draft Guidance Offers Further Info on 510(k)s for PTA, Specialty Catheters

USA – CDRH Draft Guidance Offers Further Info on 510(k)s for PTA, Specialty Catheters

The US Food and Drug Administration (FDA) on Friday released new draft guidance to help clarify the agency’s premarket submission recommendations for percutaneous transluminal...
Un hôpital chinois implante des vertèbres thoraciques imprimées 3D

China – Un hôpital chinois implante des vertèbres thoraciques imprimées 3D

Des médecins chinois ont réalisé avec succès une opération chirurgicale à Beijing en remplaçant trois vertèbres thoraciques érodées par une tumeur par des implants...
US FDA recognizes latest edition of ISO 14971 as medical device consensus standard

International – Improving Biosecurity with first International Standard for Biorisk Management

SARS, pandemic viruses and threats of the malicious use of pathogens have all woken the world up to the risks of biological materials and...
L'industrie française du matériel médical s'estime pénalisée par les lenteurs réglementaires

France – L’industrie française du matériel médical s’estime pénalisée par les lenteurs réglementaires

L'inquiétude prévaut dans le secteur assez méconnu du matériel médical, qui génère pourtant quelque 30 milliards d'euros de chiffre d'affaires annuellement. Le 26 mai prochain doit entrer...
Major Concerns Remain With MDR, Industry Group and Expert Warn

Europe – Major Concerns Remain With MDR, Industry Group and Expert Warn

As the 26 May date of application for the Medical Devices Regulation (MDR) approaches, lingering concerns about notified body (NB) capacity, a lack of...
Unique Device Identification and Recall Management: Starting with the Patient in Mind

International – Unique Device Identification and Recall Management: Starting with the Patient in Mind

This article provides an overview of FDA’s medical device Unique Device Identification System Final Rule and explains why including UDIs in health information and in...
Dutch MEB Hikes Some Medical Device Fees to Cover Rising Costs

Europe – Dutch MEB Hikes Some Medical Device Fees to Cover Rising Costs

The Dutch Medicines Evaluation Board (MEB) is hiking up the fees for some medical device services. MEB will now charge €9,000 ($10,000) for consultations...

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