10 of the Most Influential Companies in the Cardiovascular Space

International – 10 of the Most Influential Companies in the Cardiovascular Space

The cardiovascular space has been among the most exciting in medtech in recent years. A special panel at MD&M East, "Unmet Needs Straight from...
Trois nouvelles guidances du MDCG en Mars 2020

Europe – Eudamed reportedly delayed 2 years, IVDR gets 2nd notified body

Dive Brief: BSI said Monday its U.K. notified body now joins Dekra Germany as one of the two designated under the In Vitro Diagnostic Regulation. ...
Laws and regulation: Most-read stories on cosmetic regulation in APAC

France – Loi n° 2018-892 du 17 octobre 2018 relative à la désignation aléatoire...

Loi n° 2018-892 du 17 octobre 2018 relative à la désignation aléatoire des comités de protection des personnes L'article unique porte sur les comités de...
Practical guidance for procedures related to Brexit for medicinal products for human and veterinary use within the framework of the centralised procedure

Europe – TÜV SÜD Becomes Second NB to be Designated Under EU MDR

Germany-based TÜV SÜD Product Service GmbH Zertifizierstellen on Wednesday became the second notified body (NB) to be designated and notified under the EU Medical...

Europe – Passage à la loupe des paramètres laser en vue d’un marquage UDI...

Le projet confié aux étudiants de la filière "Génie des Matériaux" de la HFU était complexe : déterminer la combinaison des paramètres laser appropriés...
Designing a Drug-Delivery Device? Read This First

USA – Designing a Drug-Delivery Device? Read This First

In pharmaceutical industries, medicines are developed to treat certain illnesses. There are several types of delivery systems with which these medicines can be administered...

Europe – Garantir la conformité au RDM des dispositifs avec assemblages électroniques

Parmi les contraintes imposées par le nouveau règlement (UE) 2017/745, figurent notamment les exigences suivantes : "… éliminer ou réduire les risques autant que...
What Happens to SPCs and Patents After the Brexit Transition Period

UK – EU Exit preparedness

While the Government believes that leaving the EU with a deal is the best outcome, leaving without a deal remains the legal default at...
FDA finalizes contentious guidance on third party 510(k) reviews

USA – FDA finalizes contentious guidance on third party 510(k) reviews

FDA formalized guidance on its 510(k) Third Party Review Program this week after a consultation that saw some patient and industry groups criticize varying aspects of the...
FDA isn't doing enough to prevent medical device hacking, HHS report says

USA – FDA isn’t doing enough to prevent medical device hacking, HHS report says

The US Food and Drug Administration is not doing enough to prevent medical devices such as pacemakers and insulin pumps from being hacked, a report...

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