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Global medical resources on March 20, 2015, the British Standards Institute (British Standards Institution) BSI global master Tour: ISO 13485 DIS.2 turn version of the research and the European Union CE regulations the latest changes in share salon held in Beijing International Hotel. TEAM-NB chairman of the Institute of public announcement, BSI, EUROCAT,, a subsidiary of the German bulletin agency W. Bos Dr. Gert was invited to visit the scene, the EU's CE regulatory trends and behind the discussion to come out from the standard writer's interpretation of the authority. Nearly one hundred medical device quality regulations gathered BSI medical device Managers Club (MD Club BSI) platform to participate in interactive seminars, informed of the latest regulations, to get to know the circle of elite.
Dr. W. Bos Gert is not only the bulletin of the association of TEAM-NB, BSI, (0535), the German bulletin agency EUROCAT (NB) Certification Manager, or BSI (NB 0086) of medical regulations and clinical affairs responsible person. Regulations on clinical assessment and risk analysis are more stringent requirements, the announcement of the higher requirements of the agency's qualifications and capabilities, the emergence and implementation of the new term Audit Unannounced (flight inspection)... Not only is the enterprise, the announcement is also facing an unprecedented challenge. "At present what we can do is to follow the changes in the standard, follow the trend of the regulations to conduct audits, and actively do a good job in preparation before the flight inspection, this is very important." -- Dr. Gert stressed.
"Due to the competent authorities of the announcement of the more stringent requirements, architecture, and put forward higher requirements, a number of small notice institutions to reduce the scope of certification, and even lost the certification. In 2014, 17 of the agencies had stopped the business. The European parliament wants the 3-5's authority to be responsible for high-risk medical devices; but there are also some members who disagree, and they may be classified as high-risk products. If your product is a high risk product, you may need to consider your announcement next year is still not in, there is no such certification. You can consult your agency or BSI to be prepared to consider the integration of your resources in advance." In his speech, Dr. Gert put forward the challenges facing the public announcement.
In 2015, the world's most widely used several criteria (such as ISO 9001, ISO 14001, OHSAS 18001, ISO 13485) were entered into the key period of transition. After many discussions, the March 2015 DIS second release. The salon also invited to BSI UK CE technology experts Lane Ji Liberia teacher, the key changes in ISO 13485 DIS.2 and turn version of the process about.
"Whether it is for the standard writer, or as a standard application of enterprises, regulations is to ensure the safety of medical equipment products, to ensure the stability and long-term development of the industry." The teacher says Liberia meter. Compared with September 2014 veto DIS.1, dis new content and structure have many important changes, in the content of design control, risk management, process confirmation and put forward higher requirements, at the same time, the structure is ISO 9001: 2015 has been obvious difference.
Not only have the experts to share the announcement, the forum also has to share the best practices of the company's managers. Ms. Wang Shaohua, from Ai Bono de medical, was invited to explain the selection and verification of medical device packaging. Ms. Wang Shaohua have 20 years of medical equipment system construction and audit experience, who have reviewed GE Healthcare, Toshiba Medical, Bausch & Lomb several well-known enterprises. This is a link to allow enterprises to communicate with each other and learn, Ms. Wang Shaohua share rave reviews, make enterprise managers empathy.
International regulations change, enterprises are facing new challenges. Challenges often have, and the opportunity to communicate with experts so close, but often do not often have. Scheduled for 40 minutes of the round table discussion session, was the scene of a warm Q & A interaction and discussion delay to 1.5 hours, and extends to the online exchange platform.
The forum, participants are harvested, and sincerely hope that the follow-up to such activities can often hold: CE certification is access, is a plus, is to allow consumers to maintain confidence in you. We need such an exchange platform, the need to have the ability to have the qualifications of the body, to help us get market access, access to consumer confidence. Regulatory changes, both challenges and opportunities. The key lies in how we can learn in the first time dynamic, how to change the passive into the initiative, seize the opportunity to shuffle the market." One participant wrote the scene.
2015 is the standard era, is also the source of the standard BSI to enter China's 20 anniversary. Twenty years of excellence, to the Chinese hui. BSI in the field of participants issued 20 anniversary of the release of souvenirs. We also look forward to BSI to continue to share the most cutting-edge standards and regulatory trends, and help enterprises to follow the pace of the new requirements.
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