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Added by John Robinson on December 13, 2017 at 4:45am — No Comments
Added by John Robinson on December 5, 2017 at 6:08am — No Comments
Export, import and trade compliance principle is a very important guiding standard for governing trade policies and ensuring compliance with the set national, regional and global trade norms. It helps to define an organization’s adherence to the export, import and trade compliance principle laid out by the government and also offers an…
Added by John Robinson on December 4, 2017 at 4:50am — No Comments
Logistics and supply chain management (SCM) constitute a very important element of businesses. Getting the logistics and supply chain management aspects right is necessary for the smooth flow of products from their source to destination, during the course of which many activities need to be performed.
Logistics and supply chain management is emerging as a…
Added by John Robinson on November 29, 2017 at 4:53am — No Comments
The most critical aspect of risk management is the identification of potential areas of risk management. This helps the organization to stay focused on the areas in which it could possibly face risks, rather than taking an aimless view and shooting about in the dark.
In a very broad sense, the potential areas of risk management include all areas of a business, because simply…Continue
Added by John Robinson on November 23, 2017 at 4:41am — No Comments
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
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
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
Added by CC-Conrad Clyburn-MedForeSight on January 21, 2010 at 8:47am — No Comments
Added by CC-Conrad Clyburn-MedForeSight on March 2, 2009 at 3:30pm — No Comments
Added by CC-Conrad Clyburn-MedForeSight on December 17, 2008 at 5:59pm — No Comments