Introducing the Innovation in Medical Evidence Development and Surveillance System (IMEDS)
Posted on 06. Mar, 2017 by Karl Kapp.
For some time, the FDA has been working to establish a national resource for FDA-approved medical products that can be used by public and private-sector entities to conduct large scale evaluations of safety issues in an environment that is secure and protects patient privacy. The type of information and evaluations desired to be in the [...]
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3D Printing of Medical Devices
Posted on 27. Feb, 2017 by Karl Kapp.
The case for 3D printing within the medical device field is strong. The act of 3D printing, for those who might not know, is the process of creating a physical object from a three-dimensional digital model through the layering of the material until an object is created. The advantage is that the cost of 3D [...]
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Elements of the Software Development Plan
Posted on 23. Feb, 2017 by UL Compliance to Performance.
As more and more medical devices include sensors, controls, wireless connectivity, firmware, and remote monitoring, QA teams are adhering to best practices found in the standard IEC 62304. This standard provides the framework of lifecycle processes with activities and tasks necessary for the design and maintenance of the medical device software. The standard also focuses [...]
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FDA Oncology Center of Excellence
Posted on 20. Feb, 2017 by UL Compliance to Performance.
The FDA has recently announced the launch of the Oncology Center of Excellence (OCE). The FDA has appointed Dr. Richard Pazdur as its director. The idea behind the center is to make oncology the first disease area to have a coordinated clinical review of drugs, biologics and devices across the agency’s three medical product centers. [...]
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Medical Device Regulations In The EU – A New Era
Posted on 16. Feb, 2017 by UL Compliance to Performance.
In this current environment of continuous improvement, the medical device industry has been playing catch-up by tirelessly revising processes and documentation to meet quality standards and keep up with technological advancements. Governments and regulatory agencies are no exception. Just as FDA updates are published annually for the Code of Federal Regulations, international agencies are focused [...]
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The Value of Formal Compliance Training
Posted on 13. Feb, 2017 by Karl Kapp.
With the advent of social media and ubiquitous technology tools, there has been a large push in some circles for an increase in informal learning. Learning that occurs between co-workers and colleagues sharing institutional knowledge and procedures seems like a great idea to strengthen bonds within the company and to help reinforce critical knowledge within [...]
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A Formal Process for Managing Credits
Posted on 02. Feb, 2017 by UL Compliance to Performance.
What happens when an employee attends an outside training event – and wants to apply it to an assigned training item? For ComplianceWire® subscribers, one option is to have the learner provide a certificate, and then build an “equivalency” for the assigned training item. This moves the item from the To-Do List to the History [...]
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21st Century Cures Act Signed into Law
Posted on 30. Jan, 2017 by Karl Kapp.
In one of his last acts as President of the United States, Barack Obama signed the bill which allocated $6.3 billion to fund various efforts to eradicate cancer. The efforts include money to fund drug treatment and research as well as money for seven years of funding for other health-related initiatives. The additional funding includes [...]
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Maintaining Manufacturing Quality
Posted on 23. Jan, 2017 by Karl Kapp.
Quality or lack of quality in a manufacturing process can lead to warning letters and serious issues with the FDA. Here is a list of several infractions found in warning letters from 2016 related to manufacturing quality. The write-ups and issues in the warning letters should serve as a reminder to organizations that did not [...]
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