At MedtecLIVE as one-stop shop for medical device-related services

TÜV SÜD to take part in online trade show and congress

ID: 1566275
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(PresseBox) - The programme of the online trade show and congress with various talks, a live hack and an elevator pitch. The virtual meeting-point for medtech developers and manufacturers will be online from 20 to 22 April.

?Medical technology has to meet ultra-rigorous quality standards as well as delivering cost-effectiveness and minimising time to market?, says Norbert Stuiber, Director Global Sales & Strategic Marketing at T Device Regulation (MDR) has been postponed to this May, some manufacturers are still unaware of the General Safety and Performance Requirements (GSPR) which apply to the Regulation and with which their products must conform, such as proof of biocompatibility following a risk-based approach in line with ISO 10993.

Wireless technology is gaining ground

Further new regulations have been established in response to the spread of wireless technologies, which are governed by the MDR, but also by national standards and radio communication laws including the EU RED (Radio Equipment Directive, 2014/53/EU) and the requirements of FCC/ISED in the USA and Canada, MIC in Japan and ANATEL in Brazil. In some cases, medical device manufacturers prefer to make use of devices that are already tested and certified instead of developing their own wireless modules. While this approach saves time and costs, it requires precise instructions from the module manufacturer. ?Developers must be familiar with the regulatory requirements of the markets in question; all technical and legal aspects ? such as permissible frequency bands for local operation ? must be clarified prior to installation?, warns Thomas Ring, Senior Account Manager Global Wireless Approvals. ?To ensure national approval applications are successful, companies must take action at an early stage and ensure they can furnish seamless end-to-end documentation.?

T

? Talk ? ?Experience from the First MDR Audits ? Common Pitfalls for Manufacturers?, Dr Christiana Hofmann, Team Lead Non-Active Medical Devices (20 April 2021, 10:50-11:15 am)



? Elevator Pitch ? ?Testing Services ? T

? Talk ? ?Pr

? Talk ? ?Wireless goes global ? Internationale Zulassungen von Medizinprodukten mit Wireless-Funktionalit

? Live Hack ? hacking a simulated medical device, with Sourabh Naik, Cyber Security Expert (22 April 2021, 3:55-4:05 pm)

? Talk ? ?Cybersecurity for Medical Devices?, Jan K

About MedtecLIVE

The must-attend event in the international medical technology calendar is a virtual platform providing an overview of new developments and innovations. The exhibitors are joined by attendees ranging from suppliers, manufacturers and developers to scientists and researchers. Topics addressed at the event cover IT, materials and components and related activities as well as products and services. www.medteclive.com

About T

T

Founded in 1866 as a steam boiler inspection association, the Twable energy safe and reliable. www.tuvsud.com



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Founded in 1866 as a steam boiler inspection association, the TÜV SÜD Group has evolved into a global enterprise. More than 24,000 employees work at over 1.000 locations in about 50 countries to continually improve technology, systems and expertise. They contribute significantly to making technical innovations such as Industry 4.0, autonomous driving and renewable energy safe and reliable. www.tuvsud.com

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published by: PresseBox
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Date: 04/06/2021 - 04:37
Language: English
News-ID 1566275
Character count: 5159
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Firma: TÜV SÜD AG
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Stadt: Munich
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