The Cutting Edge of Medical Technology Content, Community & Collaboration
Both the FDA and the European Medicines Agency (EMA) have regulations that cover the labeling requirements of both prescription and over-the-counter (OTC) drugs, cosmetics, generics, medical devices, nutraceuticals and other related products. These regulations have to be strictly complied with. 21 CFR under its various parts, the Federal Food, Drug, and…
Added by Compliance4all on May 19, 2017 at 6:17am — No Comments
Added by John Robinson on April 25, 2017 at 6:18am — No Comments
Product Reliability is among the most important attributes for a product, no matter what kind of product one is considering. Product Reliability can be defined as the likeliness or probability of the product performing its stated purpose, in the light of the conditions under which it is going to be put, for a defined period of time.
The parameters used for quantification of Product Reliability are:
o MTBF or Mean Time Between Failures for products that can be repaired and…Continue
Added by Compliance4all on February 13, 2017 at 5:40am — No Comments
After carrying out the initial preclinical studies, drug manufacturers need to implement cGMP quality systems and risk management approaches during commercial development and operations in order to be able to meet the requirements of the FDA’s current Good Manufacturing Practice (cGMP), which are contained in and are governed by regulations 21 CFR parts 210 and 211.
The FDA’s guidance on cGMP quality systems and risk management approaches is meant to help drug manufacturers implement…Continue
Added by Compliance4all on February 10, 2017 at 6:08am — No Comments
Supplier selection and management is one of the critical issues for medical device manufacturers. Suppliers provide materials and services to the device manufacturer, which means that they can be critical to performance…Continue
Added by John Robinson on February 1, 2017 at 4:55am — No Comments
A look at these gigantic figures perhaps gives some perspective of the importance of document management for the medical device industry: The US total market for medical devices is valued at over $110 billion annually. It makes up nearly two fifths of…
Added by John Robinson on January 23, 2017 at 7:46am — No Comments
Japan is the world's third largest market for medical devices, after the US and Europe. Ironically, many of the world's medical device manufacturers find language barriers for communicating with Japanese regulatory authorities a greater barrier than passing…Continue
Added by John Robinson on January 12, 2017 at 4:51am — 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 Compliance4all on October 12, 2016 at 5:41am — No Comments
FDA Code of Federal Regulations (CFR) is a huge sea of regulations that the FDA has created for regulating all products that come under its purview of regulation. The FDA codes of federal regulations are numbered and cover all products, processes and the activities that go into their creation.
The FDA Code of Federal Regulations is a compendium of codified general and permanent rules the federal…Continue
Added by Compliance4all on October 6, 2016 at 5:46am — No Comments
A medical device has to mandatorily make a submission for premarket approval (PMA) to the FDA to demonstrate that the device to be marketed is substantially equivalent or at least as safe and effective as a non PMA-subjected legally marketed device. This submission is called 510 (K).
A medical device company has to submit a product for PMA when it manufactures or makes changes and…
Added by Compliance4all on May 25, 2016 at 6:07am — No Comments
COMMUNILATOR WILL HELP TRANSFORM GLOBAL MEDICINE, DOCTORS WITHOUT BORDERS, INTERNATIONAL COMMERCE, MISSION-WORK AND WAR ZONE COMMUNICATIONS
RantNetwork’s Communilator™ is the most advanced mobile phone language translation application in the world. It is capable of recognizing and translating foreign text, including books, newspapers, and menus in 54 languages and dialects captured with the host’s mobile phone camera delivering translations in over 3,000 language pairs,…
Added by Kelly Lewis on June 18, 2012 at 4:00pm — No Comments
Many harbor the concept that the recently passed reform legislation – The Patient Access and Affordable Care Act – will mean even greater advances in medical science. This is a misconception.
The reform bill is all about access to care – getting those without insurance to get insurance either through the commercial market place or through Medicaid. This will create at least 31 million more individuals with Medicaid, will keep young adults on their parent’s insurance for a…Continue
Added by Stephen C Schimpff on March 7, 2012 at 10:30am — No Comments
Added by CC-Conrad Clyburn-MedForeSight on December 13, 2008 at 6:30am — No Comments
Added by CC-Conrad Clyburn-MedForeSight on December 1, 2008 at 6:00pm — No Comments