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...

International – Using risk management to support outsourcing activities

This article outlines organizational risks and benefits with respect to third-party vendors and partnerships in regulatory affairs functions. It also discusses the different controls...
IMDRF Offers Three Final Clinical Guidelines

International – IMDRF medical device cybersecurity guidance recommends UL 2900 compliance

Recent guidance published by the International Medical Devices Regulators Forum (IMDRF) that covers medical device cybersecurity best practices includes recommendations that manufacturers comply with...

International – EFTA countries and Russia introduce COVID-19 policy changes

Our coverage of regulatory responses to the COVID-19 pandemic has featured the European Union, as well as the United Kingdom as it transitions to...

International – Antiviral and Antimicrobial Additive Developed for Face Masks, Medical Apparel

The emergence of the SARS CoV-2 virus, which causes COVID-19, has brought to the forefront another beneficial aspect of plastics — antimicrobial and antiviral...
ISO 14971 :2019 - GAP-ANALYSIS résumé versus l’ancienne version ISO EN FR 14971 : 2013.

International – Implications of the new ISO 14971 edition for usability engineering

The third edition of international standard ISO 14971 (Medical devices—application of risk management to medical devices) is now available. This third version, dated December...
IMDRF Offers Three Final Clinical Guidelines

International – IMDRF finalizes guidances on cybersecurity, personalized devices and conformity assessment bodies

The International Medical Device Regulators Forum (IMDRF) this week finalized four technical documents covering cybersecurity, personalized devices and conformity assessment bodies.   (RELATED: IMDRF Offers New Guidance...
IMDRF Offers Three Final Clinical Guidelines

International – IMDRF Consultations Focus on IVD Classifications, Regulatory Assessors

The International Medical Device Regulators Forum (IMDRF) recently released two consultations for comment on classifying in vitro diagnostics (IVDs) and improving the efficiency and ensuring regulators...

International – COVID-19: Daily Report for Life Sciences and Health Care Companies

The Daily Report is a compilation of COVID-19 (coronavirus) news briefs from around the world to help life sciences and health care companies stay current in...
Les Organoïdes supplantent désormais les méthodes In Silico dans la R&D

International – Le In Silico bientôt supplanté par les Organoïdes

Les recherches in silico (néologisme qui aurait été inventé en 1989) ont pour but de produire et présélectionner les médicaments potentiels ; elles ont le pouvoir d'accélérer...

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