2012 法规论坛
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| 第一天 – 9月26日 |
| 主持人: John Beasley, 美国MedTech Review公司高级顾问 |
| 9.30 R1 中国医疗器械法规现状及未来趋势 林森勇，上海食品药品监督局医疗器械安全监管处副处长 |
| 10.10 R2 《医疗器械生产质量管理规范》与GHTF的指导文件 徐研偌，前上海市食品药品监督管理局医疗器械安全监管处官员 会议概要 |
| 11.00 – 11.15茶歇 |
| 11.15 R3 合理利用法规资源将全球产品引入中国市场 王静嫣, 波科国际医疗贸易（上海）有限公司产品经理 |
| 11.45 R4 讨论环节：中国医疗器械法规变更对医疗器械的影响 孟茜，珀金埃尔默仪器(PerkinElmer)大中国区法规与临床事务部经理 王宇红 , 美敦力中国有限公司，或美敦力（上海）管理有限公司 |
| 12.00 – 14.00午餐 |
| 14.00 R5 欧盟法规的更新和实际应用 (英文) Jean-Pierre Boutrand医学博士，Namsa公司总经理兼科学主管 会议概要 |
| 14.30 R6 CE认证及欧盟市场准入规定更新 (英文) Faraj Abdelnour, ACIDIM协会会长，瑞典Synergus AB公司合伙人 |
| 15.00 -15.15茶歇 |
| 15.15 R7 美国FDA法规更新 (英文) 美国FDA 官员代表 Philip Brewster, Brewster Law Firm LLC律师 John Beasley, 美国MedTech Review公司高级顾问 |
| 16.30 会议结束 |
| 第二天 – 9月27日 |
| 主持人: 虞则立，上海海菲罗医疗器械科技有限公司健康服务和医疗器械法规事务总监 |
| 9.30 C1 在现有体系下执行ISO14971风险管理 (英文) John Beasley, 美国MedTech Review公司高级顾问 |
| 10.10 C2 为满足全球法规需要，临床资料在建立法令遵循制度的重要性 (英文) 汤马士奥图教授，德国 德仕天公司医学总监 |
| 10.40 – 11.00茶歇 |
| 11.00 C3 在医疗器械贸易公司建立质量体系 姜爱国, 施乐辉医用产品国际贸易（上海）有限公司质量经理 |
| 11.30 C4 于跨国公司转移项目中建立质量体系 张小群， 捷迈（中国）质量总监 |
| 12.00 – 14.00午餐 |
| 14.00 C5 供应商质量控制和及供应链的风险控制 李珺, 法国梅里埃(上海）生物制品公司高级质量经理 |
| 14.40 C6 如何准备迎接FDA 21CFR820的QSIT工厂检查， 那些是检察官关心的证据 虞则立，上海海菲罗医疗器械科技有限公司健康服务和医疗器械法规事务总监 |
| 15.30 会议结束 |
medtechinsider
Microcontroller Enables All-in-One Device for Diabetics
- Wed, 19 Jun 2013 14:29:29 +0000Integration is good, especially for diabetics. Insulin-treated diabetics typically need to to have at hand a lancet, test strips, blood glucose meter, injection device and some form of diary to manage their treatment. That’s a lot of stuff to carry around. The Brighter One device developed by Brighter AB (Stockholm) integrates all of these functions [...]
UK Royal Academy of Engineering Report Outlines Lessons Medtech Industry Can Learn from Engineering Sector
- Wed, 19 Jun 2013 07:42:28 +0000The medical device industry has much to learn from the engineering sector when it comes to demonstrating the safety of new devices, according to a report from the UK Royal Academy of Engineering. The report was produced following a roundtable discussion featuring clinicians and engineers. It was designed as a response to the upcoming revision [...]
Galway Companies Join EU Project to Develop New Medtech Manufacturing Technologies
- Tue, 18 Jun 2013 15:35:18 +0000Two companies based in Galway, Ireland’s medtech hub, are contributing their expertise to a pan-European project designed to develop new technologies for medical manufacturing, reports www.siliconrepublic.com. Crospon, founded in 2006 to develop minimally invasive surgical devices, and Adama Innovations, which was spun out from Irish nanoscience institute CRANN earlier this year, have been selected to [...]
Ethylene Oxide Sterilisation Course Offers Participants Opportunity to Discuss Products Confidentially
- Tue, 18 Jun 2013 07:54:48 +0000An interactive course offered by High Edge Consulting will provide a detailed insight into ethylene oxide sterilisation. The course will be offered on 25 June and 15 October 2013 at Holiday Inn in Birmingham, UK. The course will cover practical aspects of the process and the detailed regulatory requirements necessary to achieve compliance to [...]
Metal Alloy Could Increase Visibility of Medical Implants under X-ray
- Mon, 17 Jun 2013 21:48:34 +0000A new metal alloy could help medical implants become more visible under X-rays. The material was developed by researchers from the Materials and Surface Science Institute (MSSI) at the University of Limerick. Many implantable medical devices are made with materials that don’t show up well when using medical imaging. This can cause problems during minimally [...]
Puracon Expands Medical Packaging Footprint in Germany and United States
- Mon, 17 Jun 2013 19:54:06 +0000Puracon GmbH is expanding production capacity at its home base in Germany and plans to build a facility in the United States. The new facility at the company?s Rosenheim, Germany, location will have a 6000-sq-m production area, tripling its current footprint. As part of the construction project, Puracon has commissioned a second cleanroom. The new [...]
UK MHRA Announces Tracking System for Medical Implants
- Fri, 14 Jun 2013 07:13:26 +0000The UK Medicines and Healthcare products Regulatory Agency (MHRA) is piloting a new tracking system for high-risk medical devices. The tracking system will start in four NHS trusts and will incorporate unique device identifiers (UDIs) into patient electronic records and national Hospital Episode Statistics databases, and analysis by the Clinical Practice Research Datalink. The system [...]
Irish Engineering Student Helps Zimmer Reduce Production Bottlenecks
- Wed, 12 Jun 2013 16:14:56 +0000Zimmer Orthopaedics is eliminating production bottlenecks at its facility in Shannon, Ireland, and it has an engineering student to thank. Patrick Byrnes, who is enrolled at Cork Institute of Technology, analysed where bottlenecks occurred in Zimmer’s existing manufacturing processes as part of a competition organised by Ireland’s professional engineering body. Engineers Ireland awarded Byrnes the [...]
France Lets ?Sunshine? In: What Transparency Really Means for the Medical Industry
- Tue, 11 Jun 2013 15:06:35 +0000As reported in medtechinsider on 31 May 2013, France has implemented the remaining sunshine regulations. The regulations are an extension of the Bertrand law, which was passed in 2011, requiring all healthcare-related enterprises to exercise greater transparency in their relations with customers. In this article, Ren Clment, co-chair of Medimark Europe, which serves as an [...]
Medical Device Regulations Draft: MEPs Propose more than 900 Amendments
- Mon, 10 Jun 2013 17:05:44 +0000The new medical device regulations might change significantly from the original draft report proposed by the European Commission or the version introduced by Rapporteur Dagmar Roth-Behrendt. This became clear as the Committee on the Environment, Public Health and Food Safety (ENVI) debated the device regulations and MEPs added their amendments to the regulations last month. [...]
