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Health Education England is launching an online workshop to gather views on digital readiness.
The organisation is working in collaboration with Digital Health and innovation and crowdsourcing agency Clever Together on the online workshop, which forms part of the…
Added by John Robinson on November 14, 2017 at 5:32am — No Comments
Murj, a new company backed by $4.5 million in new venture financing, is looking to make data collection from implantable heart monitoring and management devices easier and more manageable.
The company was founded by a former Medtronic sales rep who’d previously worked as a product manager on Apple’s iPads. After a few years in sales, Murj founder Todd…
Added by John Robinson on November 8, 2017 at 5:39am — No Comments
Process validation is the method of using data from stages ranging from the process design stage to production, to ensure that the process that is being used can deliver consistently high-quality products. Companies that come under the life sciences must comply with GxP regulations to ensure that their processes meet the regulatory guidelines to be GxP compliant.…
Added by John Robinson on November 8, 2017 at 5:37am — No Comments
In a scenario where today’s healthcare environment is fast paced, diverse and straddle many disciplines; retention and disposition of medical records -both paper and electronic -is fraught with complexities. There are different rules set out by the state agencies, as well as by HIPAA statutes and regulations, for the way in which medical records need to be retained…
ContinueAdded by Roger Steven on October 11, 2017 at 7:12am — No Comments
Instances of cyberattacks that lead to disruption of service, data theft or compromise and even ransomware are making the news headlines of late with alarming frequency. Cyberattacks are carried out because computer systems used in highly regulated companies house very sensitive and valuable information.
Data relating to valuable electronic submissions, clinical information, medical device design control records, legal information, and other such information are usually placed in…
ContinueAdded by Adam Fleming on October 10, 2017 at 6:26am — No Comments
The introduction of the Electronic Health Record (EHR) has certainly brought about a major change in the way healthcare is administered in this vast country.
EHR's have evolved in a big way from the time they first came to be used in a moderate way in the healthcare industry a few decades ago. From then on, although the push towards making all health records online has been on -and the US economy saves close to $80 billion a year on paper and other aspects -the rate of penetration of…
ContinueAdded by Roger Steven on September 21, 2017 at 7:25am — No Comments
The core of successful operation by a drug maker is laboratory testing. current Good Manufacturing Practices (cGMP) regulations require a drug manufacturer to use laboratory testing as a tool to validate that everything that goes into a laboratory product, such as in-process materials, finished materials, and containers adhere to set specifications. When all these are done, a major challenge for laboratories is in how to deal with a test that shows an…
Added by Adam Fleming on September 12, 2017 at 5:59am — No Comments
Most pharmaceutical biofilms, especially those in water systems, suffer from one major flaw: misconceptions. Strict and rigid rules for design and operations, especially when they are built on…
Added by John Robinson on September 4, 2017 at 6:34am — No Comments
The FDA’s regulations on cleanroom environmental monitoring (EM) are based on the assumption that any person who enters a cleanroom is likely and almost certain to have brought contaminants in one or another form with him. The FDA’s regulations on cleanroom environmental monitoring are built on the thinking that microorganisms can assail even the cleanest of systems, which is why its regulations on cleanroom…
ContinueAdded by Adam Fleming on August 9, 2017 at 5:39am — No Comments
Electronic Health Records (EHR) or electronic medical records (EMR), as they are called, are of enormous use in the fields of healthcare and medical sciences. They have a number of features that enable the patient; the medical professional and the healthcare provider have complete and unimaginably easy access to all important records that relate to the patient.
A direct result of the…
ContinueAdded by Roger Steven on June 29, 2017 at 7:52am — No Comments
Establishing Quality Systems is one of the central aspects of a medical device and/or pharmaceutical organization. Establishment of Quality Systems is also a regulatory requirement, as set out by the FDA and the ISO.
The process of establishment of Quality Systems for FDA-regulated medical devices industries is set out in 21 CFR Part 820. Further, the ISO has its standard for how to establish Quality Systems in medical devices industries –the ISO 13485 standard…
Added by Adam Fleming on March 28, 2017 at 9:06am — No Comments
Computer system validation process is described as the documented procedure which assures that a computer system performs the exact functions it is intended to reproducibly, consistently and verifiably. The computer system validation process covers every function and milestone of the computer system:
Added by Adam Fleming on June 7, 2016 at 2:24am — No Comments
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