Medical devices are regulated in the EU by the Medical Device Regulation (MDR), which came into force on 25 April 2017 and into application on 26 May 2021. The demand for regulation arose from the need to establish a transparent, robust, predictable, and sustainable regulatory framework. This...
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As the company's international flagship product, VenusP-Valve received CE marking under the Medical Devices Regulation (MDR) on April 8th, 2022, becoming the first Class III implantable cardiovascular device approved under the new MDR. In 2023, after receiving Investigational Device Exemption (IDE) ...
a leading provider of integrated solutions for transcatheter structural heart valvular therapies inChina, announced today that, VenusP-Valve, the company's in-house developed innovative transcatheter pulmonic valve replacement (TPVR) system, cleared approval from Health Canad...
As the company's international flagship product, VenusP-Valve received CE marking under the Medical Devices Regulation (MDR) on April 8th, 2022, becoming the first Class III implantable cardiovascular device approved under the new MDR. In 2023, after rece...
One revolutionary development in digital health technology is software that can perform complex medical functions— software as a medical device (SaMD). SaMD can diagnose conditions, suggest treatments, and inform clinical management. Back to top Reimagining digital health regulation: An agile model ...
These new AI analytic modules will provide DIAGNOS with the opportunity to grow its revenue faster. The modernisation of our Health Canada license was required by both current clients, the Quebec government as well as be...
Medical device makers’ IPO plans signal upturn in flat listings market Kestra Medical Technologies and Heartflow make non-invasive cardiac tests for patients with heart conditions January 18 2025 Data PointsJohn Burn-Murdoch Young people are hanging out less — it may be harming their mental health...
Medical PhysicsMedical Device Safety: The Regulation of Medical Devices for Public Health and Safety - Higson - 2001 () Citation Context ... documents concerning thesMedical Device Vigilance System in the European Union (MEDDEV documents).s7sAccording to Pelkmans et al (2000), and other ...
National Health Service ‘Better than lying on the floor at home’: how corridor care became the norm in the NHS About 70% of nurses in the UK are delivering care in ‘inappropriate’ settings, says union FT MagazineDisease control and prevention ...