Medical Devices Regulatory Europe

New Rules For CE Marking Medical Device Machines - International

  • 2013-07-23 08:36
  • PR Newswire
  • [PRNewswire / Shanghai]

Shanghai July 23, 2013 / PRNewswire PRNewswire / - CPhI Conferences organized by the Innovation Technology Forum and Regulatory Summit 2013 ) will be held September 24 to 26 at the Shanghai World Expo Exhibition and ninth MEDTEC China exhibition held concurrently. The summit will be updated as new technologies and regulatory focus, continuity MEDTEC exhibition will be high-quality, multi-dimensional discussion of all aspects and features. The meeting adopted the form of modules, six modules are shown as "Chinese regulatory updates with the fact that analytic", "medical equipment design and innovation", "foreign regulatory updates and market access", "wireless medical / mobile medical" "Medical device clinical trials" and "Risk Management and Quality Control" as the theme, each module will be arranged under the theme of four professional speaker, providing authoritative, comprehensive and in-depth industry information sharing opportunities. To cope with the arrangements MEDTEC exhibitors and visitors to visit on a daily basis will arrange a half-day meeting held in conjunction with two modules, two from the regulations and technical point of view, the maximum extent to meet the needs of the audience. Summit will be invited from government regulators, medical equipment manufacturers and research institutions a total of 20 speakers over names of participants, has been confirmed from the FDA China Office, SFDA Shanghai, China Academy of Food and Drug fixed (NIFDC) Medical Device Testing Center , Terumo, minimally invasive medical and ACIDIM association of senior experts to attend. Detailed schedule meetings, please visit download.

(Photo:

Organizers carefully selected a number of outstanding professionals, industry information for you free download (click on the title, immediate download):

1 "U.S. high-risk medical devices for the management of pre-market approval - PMA

[Speakers] Chang Wing Hang, the State Food and Drug Administration / China Center for Pharmaceutical International Exchange

[Glance] - PMA Review

- The situation and the need to fulfill information requirements PMA

- PMA approval procedures

- PMA charges

2. "European Medical Device CE certification

[Speakers] Bo, SGS International Certification Services

[Glance] medical device regulations around the world (U.S., Japan, Canada, Australia, etc.)

3 "implantable medical device supervision and inspection requirements analysis

[Speakers] Song Duo, the State Food and Drug Administration / Tianjin Medical Device Quality Supervision and Inspection Center

[Glance] - China's current medical device regulatory approach compared with foreign countries

- Implantable Medical Device Standards

- Implantable Medical Device Testing

- Implantable medical device adverse event monitoring

If you can not download, please use the connection:


Cars sales here http://usedauto-usa.com/s/state-california--town-sanger - usedauto-usa.com
2007-09-08 13:08:25 by -------

Chip implants shown to cause cancer, a

-
"When the U.S. Food and Drug Administration approved implanting microchips in humans, the manufacturer said it would save lives, letting doctors scan the tiny transponders to access patients' medical records almost instantly. The FDA found "reasonable assurance" the device was safe, and a sub-agency even called it one of 2005's top "innovative technologies."
But neither the company nor the regulators publicly mentioned this: A series of veterinary and toxicology studies, dating to the mid-1990s, stated that chip implants had "induced" malignant tumors in some lab mice and rats

2007-09-10 10:57:42 by BabyKanuk

Chip Implants Linked to Animal Tumors

When the U.S. Food and Drug Administration approved implanting microchips in humans, the manufacturer said it would save lives, letting doctors scan the tiny transponders to access patients' medical records almost instantly. The FDA found "reasonable assurance" the device was safe, and a sub-agency even called it one of 2005's top "innovative technologies."
But neither the company nor the regulators publicly mentioned this: A series of veterinary and toxicology studies, dating to the mid-1990s, stated that chip implants had "induced" malignant tumors in some lab mice and rats.
"The transponders were the cause of the tumors," said Keith Johnson, a retired toxicologic pathologist, explaining in a phone interview the findings of a 1996 study he led at the Dow Chemical Co

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