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All Blog Posts Tagged 'Global' (7)

Managing a medical device recall efficiently and effectively

A medical device recall means the correction or removal of a device for human use where FDA finds that there is a reasonable probability that the device would cause serious, adverse health consequences or death. It is an action taken to address a problem with a medical device that violates FDA law. Recalls are made when a) a medical device is defective; b) when it could be a risk to health, or c) when it is both defective and a risk to health.…


Added by Compliance4all on November 11, 2016 at 4:39am — No Comments

Diligence is Necessary for Postmarketing Vigilance Reporting for Medical Device Manufacturers

A few important postmarketing vigilance revisions are now being implemented. One of these is the revised medical device guidance document on postmarketing vigilance (MEDDEV 2.12-1 rev 5), which came into force on January 1, 2008.

Offering greater clarity and more guidance than the previous version, the new document includes new reporting terminology and many new concepts. It has also excised or added new, important terms.…


Added by Compliance4all on October 26, 2016 at 5:59am — No Comments

Device Establishment Registration and Listing in line with the FDA’s Proposed Rule

Annual registration is a requirement for any device firm, establishment or facility whose business relates to the production and distribution of medical devices intended for use in the US in some or another way.

Such business establishments have to register with the FDA and also need to list the devices that are made there and the activities that are performed on those devices.…


Added by Compliance4all on October 20, 2016 at 5:59am — No Comments

"Crisis Commons" ... Haiti Earthquake Relief - Open Source, Real-Time Networks, Info & Maps


Thank you to MedTech-IQ members Michael Russel and Bart Stidham for informing me about CrisisCommons, host of CrisisCamp, at: Crisis Commons is an international volunteer network that creates open source tools for responders to mitigate disasters.

Crisis Commons includes:…


Added by CC-Conrad Clyburn-MedForeSight on January 21, 2010 at 8:47am — No Comments

Telemedicine in Haiti ... A Humble Assessment of Where We Are


First, I want to thank the many of you who have shared your thoughts on how emerging medical technologies - Telemedicine, mHealth, Distance Learning, ect.. - can be used to support the humanitarian relief efforts in Haiti. Clearly, this community has a great deal to offer.

As we all can see, the acute phase of the disaster relief response is still coalescing. Consequently, while conditions on the ground are improving, they are still chaotic. As in all major… Continue

Added by CC-Conrad Clyburn-MedForeSight on January 20, 2010 at 7:00pm — 2 Comments

New Member Update...2 March 2009


Thanks to your efforts, the MedTechIQ community continues to grow and attract new members, along with their talents and collective experience. We are all, in the end, potential digital resources for each other.

Please remember ... one of the most useful ways to leverage the MedTechIQ network is to explore the "Search" boxes. They efficiently open up for you multi-media information resources and potential expert contacts. Both the universal search, in the upper… Continue

Added by CC-Conrad Clyburn-MedForeSight on March 2, 2009 at 3:30pm — No Comments

Institute of Med (IOM): U.S. Commitment to Global Health - Recommendations for New Administration


As just released by IOM...GLOBAL HEALTH SHOULD BE KEY COMPONENT OF U.S. FOREIGN POLICY...The U.S. should significantly intensify its commitment to global health in the next four years by increasing funding and placing greater importance on health when setting overall U.S. foreign policy, says a new report from the Institute of Medicine written to inform the incoming administration's future policies. To achieve this level of commitment, a White House Interagency Committee… Continue

Added by CC-Conrad Clyburn-MedForeSight on December 17, 2008 at 5:59pm — No Comments

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