France – Choisir une méthodologie statistique pour l’évaluation clinique d’un DM
La diversité des dispositifs médicaux (invasifs, non invasifs, diagnostiques, thérapeutiques, de surveillance), leur développement croissant ainsi que l’évolution de la réglementation associée à ces...
Europe – Amendement des normes IEC 60601 : les impacts sur l’évaluation des DM
Publiée pour la première fois en 1977, la norme IEC 60601-1 décrit les exigences générales de sécurité et de performances applicables aux dispositifs électro-médicaux....
International – IMDRF guidances address cybersecurity, personalized devices and surveillance
The International Medical Device Regulators Forum (IMDRF) released four final guidances this week that address cybersecurity best practices, verification and validation for personalized medical...
Europe – Transition to MDR underway for 63% of outgoing Directives certificates
The number of applications for certification under the Medical Device Regulation (MDR) almost doubled to 9,615 last year, according to a survey of notified...
USA – EPA proposes rules on EtO with implications for medical device sterilization
The US Environmental Protection Agency (EPA) has proposed two much-anticipated rules that would restrict how much ethylene oxide (also referred to as EO or...
France – Solutions d’informatique embarquée pour les DM à base d’IA
Le big data, l'apprentissage automatique (Machine Learning) et l'intelligence artificielle (IA) permettent d'obtenir des informations approfondies en analysant de grandes quantités de données issues...
Switzerland – Switzerland, too, extends medical device certifications to safeguard supply
Switzerland plans to extend the certification of medical devices to match changes in the EU and reduce the risk of supply disruption.
Recently, the EU...
USA – FDA draft guidance allows AI/ML devices to evolve without requiring new submissions
The US Food and Drug Administration (FDA) published a draft guidance outlining how sponsors of artificial intelligence and machine learning (AI/ML) products can submit...
USA – FDA releases draft guidance for non-spinal orthopedic bone fixation devices
The US Food and Drug Administration (FDA) has released a new draft guidance outlining what information should be included in premarket submissions for orthopedic...
USA – Guidance gives FDA authority to reject devices due to poor cybersecurity
While final guidance gives the US Food and Drug Administration (FDA) the authority to deny a new product application the product’s cybersecurity measures don’t...
