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ISO 14971:2012 and IEC 62304:2006 are related but different global standards for risk management pertaining to software used in medical devices. Judicious application of these two standards is the way to go for medical device companies.
ISO 14971 and IEC 62304:2006 are global…Continue
Added by John Robinson on January 13, 2017 at 4:54am — 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
Added by John Robinson on January 11, 2017 at 5:01am — No Comments
Though short in length,HIPAA Security Rule principles are well defined in some areas, but vague in some others, making implementation of these areas difficult.
HIPAA Security Rules are an offshoot of the Privacy Rule. While Privacy Rule concerns itself with Protected Health…Continue
Added by John Robinson on January 10, 2017 at 4:45am — No Comments
In order to ensure GMP compliance, pharmaceutical laboratories have to devise a holistic and long term plan that covers all aspects of the laboratory's activities.
Good Manufacturing Practices (GMP) requirements for laboratories have been set out by various…Continue
Added by John Robinson on January 9, 2017 at 6:00am — No Comments
Software Validation Process for 21 CFR Part 11 is all about authenticity and integrity of electronic signatures and records. Care should be taken to avoid confusion and get validation right.
The FDA’s Code of Federal Regulations (CFR) is a collection of laws that regulate the various…Continue
Added by John Robinson on January 6, 2017 at 4:35am — No Comments
Added by John Robinson on June 6, 2016 at 2:33am — No Comments