TÜV Rheinland Blog - Stories from Asia and Africa

How To Maximise The Use of Your Medical Imaging Equipment

Posted by TUV Rheinland on Oct 8, 2018 10:46:19 AM

In the ASEAN region, changes in medical imaging are experiencing two (2) key drivers:

  1. The transition from film-based imaging to filmless imaging (computed radiography/direct radiography), and
  2. The expansion/increase of availability of previously experimental/high-end modalities, such as cardiac angiography, positron emission tomography (PET/CT), etc.

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Topics: medical, Certification, Risk Management

How Smaller Businesses can Receive ISO 13485 Certifications Quickly and Affordably

Posted by TUV Rheinland on Feb 28, 2018 3:34:27 PM
The topic of software usage in ISO 13485:2016 (the Quality Management System for Medical Devices industry) often raises tough questions that slow down the implementation of the management system. This includes software used in the quality management system, software used in production and service provision, and software used for the monitoring and measurement of requirements.

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Topics: systems, Certification, medical

TÜV Rheinland Helps Delta Electronics Secure First Medical-Grade Certification for High-Voltage X-Ray Power Generators in Taiwan

Posted by TUV Rheinland on Feb 23, 2018 11:26:54 AM

Delta Electronics has achieved another breakthrough in the power-supply sector with its latest development – a high voltage generator for X-ray equipment, which recently received medical device certification by the global testing and certification leader, TÜV Rheinland. Achieving compliance with the European Union (EU) MDD 93/42/EEC medical devices directive, and receiving EN ISO 13485 medical quality management system certification is an industry milestone that makes Delta the first power-supply manufacturer in Taiwan capable of manufacturing medical-grade high-voltage generators for X-ray equipment.

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Topics: medical

Cybersecurity risks in Healthcare are as real as virus in hospitals

Posted by TUV Rheinland on Aug 14, 2017 11:23:44 AM

In the last few years we have seen breakthroughs in the IT industry, innovations in medical devices, and software that has brought in a paradigm shift in the healthcare services sector. These technological advancements and healthcare IT solutions promise a brighter, healthier future for mankind. It has become inevitable that, today’s healthcare stays in pace with the current technological developments in the field. Today's hospital is already equipped with advanced gadgets and powerful digital technology and tomorrow will have a much more effective healthcare technology. These advancements provide doctors with crucial data points to take critical as well as effective decisions, which ultimately improve quality of treatment and overall experience of the patient.

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Topics: medical, cybersecurity

TUV Rheinland Hosts ISO 13485:2016 Quality Management System Certification Seminar for Medical Devices

Posted by TUV Rheinland on Apr 13, 2017 11:21:08 AM

TÜV Rheinland Korea hosted a seminar on ISO 13485:2016, a new medical device quality management system certification, earlier revised in March 2016. The seminar, titled “Introduction and Understanding of ISO 13485: 2016,” was prepared in collaboration with TÜV Rheinland Japan and presented at the Korea International Medical & Hospital Equipment Show (KIMES) on March 17th 2017.

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Topics: medical

TUV Rheinland Korea and Gwangju Technopark Sign an MOU on Healthcare Robots

Posted by TUV Rheinland on Apr 13, 2017 11:18:25 AM

TÜV Rheinland Korea signed an agreement on March 16th with Gwangju Technopark for mutual business cooperation in the healthcare robot industry.

Both parties agreed to establish an official system of cooperation, which will in turn facilitate the correspondence of experiences necessary to construct a healthcare robot test bed at Gwangju Technopark, and galvanize the exchange of information on certification and evaluation as well as human resources for the development of professional technology.

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Topics: medical

Capturing the Mobility Aids Market in an Aged Society

Posted by TUV Rheinland on Mar 9, 2017 12:00:00 PM
Capturing the Mobility Aids Market in an Aged Society | cn | TÜV Rheinland

On February 15, 2017 (Wed), TÜV Rheinland hosted a mobility aids safety forum in Taichung. The forum focused on export quality and European standards requirements for mobility aids. During the forum, experts from related industries, including Dr. Chang Wan-Lan from the Cycling & Health Tech Industry R&D Center and Mr. Arthur Shen, project manager from the Precision Machinery R&D Center, each gave an explanation of wheelchair standards and common deficiencies found during FDA review and testing. TÜV Rheinland experts then introduced quality requirements and solutions for mobility aid manufacturers exporting to the EU, so as to help manufacturers grasp the key regulatory highlights pertaining to mobility aids.

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Topics: Product Certification, medical

TÜV Rheinland Showcasing at MEDICA 2016

Posted by TUV Rheinland on Nov 12, 2016 3:42:06 PM

TÜV Rheinland is again attending MEDICA 2016 this year, which is taking place from November 14 to 17, in Dusseldorf and will be presenting numerous current topics. The world’s leading trade fair in the medical industry has been marked as a must-attend event in every expert’s calendar for more than 40 years. Last year, it attracted more than 130,000 visitors.

As a leading international provider of technical services in the areas of testing, inspection, certification, advice and training, TÜV Rheinland is providing information on the pivotal topics of the medical industry at this year’s MEDICA. The testing service provider’s “hot topics” include the evaluation of wireless technologies and the evaluation of cyber security .

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Topics: medical

TÜV Rheinland Japan is extending cooperation and collaboration with Fukushima Prefecture on medical equipment field

Posted by TUV Rheinland on Sep 12, 2016 10:00:00 AM

TÜV Rheinland Japan Ltd. and Fukushima Prefecture have been extending their cooperation and collaboration in the field of medical equipment for about a year. This effort is the outcome of a memorandum of understanding concluded in October 2015 between TÜV Rheinland and the Prefecture. On 2 September 2016, Mr. Toshiyuki Hata, Vice Governor of Fukushima Prefecture, paid a courtesy visit to the TÜV Rheinland Headquarters in Germany and reported on the cooperative achievements of the past year. TÜV Rheinland Japan has announced that they have discussed with Vice Governor Hata cooperation plans for the "Fukushima Medical Device Development Support Centre", which is scheduled to be completed in November 2016.

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Topics: medical, healthcare

Medical Industry Brief: IEC 60601-1-11 Home Healthcare Environment

Posted by TUV Rheinland on Mar 15, 2016 10:00:00 AM

The near-universal adoption of high-speed broadband internet and telephone networks, smartphones and the tsunami of apps both entertaining and practical, as well as affordable electronic devices have all opened the doors for moving healthcare from the hospitals to home.

As populations continue to age and life expectancy increases, more and more patients need affordable, reliable and convenient professional medical services at home.

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Topics: medical, healthcare