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Ensuring Cybersecurity for Medical Devices: FDA's Postmarket Guidance

On December 28, 2016, the Food and Drug Administration (FDA) issued crucial guidance to inform industry and FDA staff of the Agency’s recommendations for managing post-market cybersecurity ...
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Ensuring Medical Device Effectiveness and Safety

By Bhavya H M, Sr. Executive, Business development, TÜV Rheinland India
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TÜV Rheinland: Notified Body for the New Medical Device Regulation

TÜV Rheinland LGA Products GmbH is now a notified body for the EU Medical Device Regulation (MDR) 2017/745 / Introduction of Eudamed central database / Increased requirements for notified bodies.
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A Wireless Medical Device May Have a Great Design, But Is It Safe?

Device manufacturers are usually familiar with proper design methods for devices, but often get lost navigating through the standards and regulations necessary for developing wireless medical ...
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Common Requirements for X-Ray Diagnostic Equipment

Since the discovery of radiation and radioactivity more than 100 years ago, radiation protection standards and the philosophy governing those standards have evolved. Proper evaluation of these ...
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Are We Ready for Medical Robots?

In the coming years, it will be more and more likely to see robots in our everyday lives, whether it be at the store, in our cars, or even in our hospitals. In fact, the medical robots market is ...
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Planning to Enter the Medical Device Field in Japan? Get Familiar With the PMD Act

In November 2014, Japan enacted the Pharmaceutical and Medical Device Act, or PMD Act. Officially called “The Act on Securing the Quality, Efficacy and Safety of Pharmaceuticals, Medical Devices, ...
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TÜV Rheinland India approved as a Notified Body by CDSCO, India

TÜV Rheinland India, a subsidiary of the TÜV Rheinland Group, Germany, a worldwide leader, that inspects technical equipment, products and services, oversees projects, and helps to shape processes ...
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What You Need to Know about the new ISO 13485 (2016) for Medical Devices

About the Author: Uwe Meyer Certification Manager, TUV Rheinland Medical Uwe is responsible for management of the Medical Devices Testing business unit, bringing with him 20 years of experience in ...
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How X-Ray Research Has Led to IEC Safety Standards

X-Ray: A Brief History In 1895, German physicist, W.C. Roentgen discovered the X-ray. He found that the right mixture of gasses and high electric voltage would produce an “invisible light,” or ray, ...
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