Advice for Management of Clinical trials in relation to Coronavirus

UK – Action taken to halt sales of fingerprick coronavirus (COVID-19) antibody testing kits

The MHRA is asking providers of laboratory-based COVID-19 antibody testing services using capillary blood collected by a fingerprick, to temporarily stop providing this service...

Canada – Health Canada releases guidance to streamline COVID-19 clinical trials

Health Canada Wednesday issued two guidance documents designed to streamline clinical trials for medical devices and drugs that are related to COVID-19. The guidance documents...
New guidance on biologics affects authorized generics

USA – US FDA to temporarily accept changes to devices approved through PMA or...

The US Food and Drug Administration (FDA) published a noteworthy new guidance document this month, “Supplements for Approved Premarket Approval (PMA) or Humanitarian Device...

France – Coronavirus & dispositifs médicaux : et demain ?

Dans le domaine de la santé, le secteur des dispositifs médicaux a été fortement impacté par le coronavirus ; la situation reste cependant extrêmement...

France – Qualification de dispositif médical : quoi de nouveau sous le soleil ?

Le dispositif médical se définit, aux termes de l’article L.5211-1 du code de la santé publique, comme «(…) tout instrument, appareil, équipement, matière, produit, à l’exception...

Europe – European Commissioners loosen some MDD, AIMDD designation renewal requirements for Notified Bodies

The European Commission has published new regulations to ease designation renewals to current Medical Device Directives ahead of the Medical Devices Regulation’s (MDR) new...

France – La contribution sur les dépenses de promotion des dispositifs médicaux

Les entreprises concernées par cette contribution Sont assujetties à cette contribution les entreprises dont le chiffre d’affaires hors taxes réalisé au cours du ou des...
Advice for Management of Clinical trials in relation to Coronavirus

Europe – Medical devices: guidance for manufacturers on vigilance

Be aware that two new EU Regulations entered into force on 25 May 2017, namely: Regulation 2017/745 on medical devices (EU MDR) Regulation 2017/746 on...

France – Nordson EFD aide les fabricants à répondre à la demande de DM...

Le 25 mars dernier, Nordson EFD est contacté par un intégrateur de systèmes robotiques qui souhaite commander de nombreux systèmes de dosage automatisé afin...

International – Medical Writing: The Language and Art of Scientific Communication

Medical writers (MWs) are professionals from diverse backgrounds who address different business needs. Writers hone their skills over the years and master the art...

NOS PROCHAINES FORMATIONS