TheEUAIActproposescreatingcoordinatedAI“regulatorysandboxes”toencourageinnovationacrossEurope. Thesesandboxesallowbusinessestotestandrefinetheirnewproducts,services,orbusinessmodelsunderthe supervisionofregulators.Thiscontrolledenvironment givesinnovatorsasafespacetoexperimentwhilehelpingregulatorsunderstandnewtechnologiesand...
Overcome all of your EU MDR, IVDR, Software & AI, UKCA and Global Regulation hurdles in one place, including focused Clinical, Post Market Surveillance, Law & Compliance, and Biocompatibility discussions. Join Competent Authorities, Notified Bodies and i
New regulatory frame in Europe - MDR challenges for all the stakeholders Compliance strategies to fulfil the requirements – ROBUST RECEPTION Lessons learned from our experience Cristina Miroescu-Compliance Director,SOFMEDICA GROUP 17:00-17:45
The MedTech industry is undergoing extensive changes with the advent of theEuropean Union Medical Device Regulation(EU-MDR) framework, a comprehensive set of regulations being implemented across Europe. It establishes more stringent requirements to mitigate the negative impact of hazardous substances in m...
An Exciting Week for Medtech in Europe – Combining Today's Implementation With Tomorrow's Improvements Read in this blog by Gert Bos about recent regulatory conferences in Europe, including the RAPS Euro Convergence and Irish MedTech conferences, where participants actively engaged in discussions abou...
Within the next five years (by 2023), Asia will eclipse Europe to become the second-largest regional market. During that period, Asia will also be the major growth engine among global medtech markets, contributing 35 percent of total incremental growth (Exhibit 1). 1 Put simply, the strong...
Europe Asia FX Rates Futures Crypto RangeDropdown Markets1D5D1M3M6M1Y2Y Asia Dow4,110.026.760.16% Nikkei 22538,283.85257.680.68% Hang Seng19,229.97-371.14-1.89% Shanghai3,267.19-103.21-3.06% Sensex79,117.111,961.322.54% Singapore3,746.026.800.18% ...
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As one of Europe’s leading development and production partners of medical technology products,Elos Medtechcontinuously focus on updates and developments in the medtech industry. When it comes to UDI, we are preparing to provide solutions based on our customers demands. With patient safety as Elos...
In April 2022, VenusP-Valve became our first independently developed product marketed in Europe, and also the first self-expanding TPVR product approved in Europe. Besides, VenusP-Valve was approved by the NMPA in July 2022 for the treatment of patients with severe pulmonary regurgitation (≥3+...