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Bureau Veritas Certification assists Mascot well understanding of Medical Device - Risk management applications
Bureau Veritas Certification assists Mascot well understanding of Medical Device - Risk management applications

Bureau Veritas Group (Bureau Veritas, “BV”) successfully provided 2 days ISO14971:2007 In-house training course service to "Mascot Power Supplie (Ningbo) Co Ltd." and awarded certificates to 10 participants who pass the examination.

Founded in 1938, Mascot is one of Scandinavia's leading manufacturers of quality power supplies and intelligent battery chargers. As one of 3 wholly owned subsidiaries and production facilities, Masco Power Supplie (Ningbo) Co. Ltd is doing design and production for global markets. Electro-medical industry develops rapidly these years. The global medical device market has reached 10.6% annual growth rate, and the global trading amount increases at 25% every year. The quality of a medical power supply is very important to ensure a medical device’s safety and performance.

ISO14971 is about the application of risk management to medical devices. We can see the concept of risk management has been addressed in various quality management systems and product requirement, eg. ISO9001:2015, IEC60601-1:2005 3rd edition and its amendment 1. Also in ISO13486:2016, published on Mar. 1st of 2016, risk management has been stated as a clause in this new standard. Since risk management does not use a standard or has acceptable risk levels, some manufacturers feel quite difficult to start. ISO14971 with its updated versions well defines terminology to make it not only understandable but also easy to implement with its framework and annexes.

During the course, the facilitator Marvin Ng, also the GC medical device technical manager of Bureau Veritas Certification, brought everybody a full picture of ISO14971 with 7 chapters of contents and exams, including,

-Introduction to Risk Management
-Risk Management Policy and Plan,
-Intended Use and Hazard Identification,
-Risk Estimation and Evaluation,
-Option Analysis and Risk Control,
-Overall Residual Risk Evaluation, and
-Risk Management Report and Post Production Information.

The course was greatly welcomed by all attendees from Mascot, they enjoyed the training, took every chance to ask and to respond, and completed all group discussion in a high standard quality. After the class, they could identify the emerging global requirements for risk management, explain the scope and limitations of ISO 14971, determine how a risk management system fits into a quality management system, identify how and where to use the various tools for risk management, and apply ISO 14971 to discussed example in terms of risk analysis, risk evaluation, and risk control. At the same time, Bureau Veritas Certification highly appreciates Mascot's trust and cooperation, we are also very proud to accompany our client in their continuously improvement.

As one of the biggest certification organizations, Bureau Veritas is ready to provide various services for global markets, for example, ISO13485:2016,ISO14971:2007 quality management system certification and their internal auditors qualification, CE on EU MDD/IVD Directives, RCB certification (Ninsyo) upon Japan JPAL, InMetro certification and ANViSa registration for Brazil market, etc. With our professional certification and training services, Bureau Veritas and our clients always move forward with confidence.

About Bureau Veritas

Created in 1828, Bureau Veritas is a global leader in Testing, Inspection, Certification and Technical consulting, delivering high quality services to help clients meet the growing challenges of quality, health, safety, environmental protection and social responsibility. As a trusted partner, Bureau Veritas offers innovative solutions that go beyond simple compliance with regulations and standards, reducing risk, improving performance and promoting sustainable development. Bureau Veritas core values include integrity and ethics, impartial counsel and validation, customer focus and safety at work. Bureau Veritas is recognized and accredited by major national and international organizations.

Bureau Veritas has more than 61,600 employees in 1330 offices and laboratories located in 140 countries. Bureau Veritas entered China in 1882 with currently more than 10,000 skilled employees in 99 offices and laboratories located in 55 cities.

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Bureau Veritas Certification (BVC) former known as “BVQI” Bureau Veritas Quality International, was formed in 1988, is one of the independent subsidiary of Bureau Veritas (BV Group). As part of an international company with many core business platforms, Bureau Veritas Certification provides several certification services, with one of its specializations on quality & environment. In Hong Kong, "Bureau Veritas Certification Hong Kong Limited" is Bureau Veritas (BV Group) officially approved branch office to provision the ISO 9001, OHSAS 18001, ISO 14001, ISO50001, ISO14064, ISO10002, SA8000, ISO26000, ISO20000, ISO27001, FSC, PEFC, TAPA, ISO28001, ISO55001, ISO22000, FSSC22000, HACCP, GMP, ASR Sustainability Report, AS9100 and ISO/TS 16949 certification services……etc

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