Viewpoints
Writing Technical, Practical, and Theoretically interesting blogs
Role of Human Errors in CAPAs
What is a “HUMAN ERROR”? Is it a Human error? Can we prevent these error occurrences? What could be the possible cause or situation which leads to these “Human error”? FDA is very serious about Root cause analysis and effective CAPA management, but when most of the RCA comes to a conclusion as “Human error”; it is not accepted by FDA. We must analyse all the...
Aug 19, 2023
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FDA Guidance on SaMD
The FDA has released a final guidance entitled “Content of Premarket Submissions for Device Software Functions” on premarket submissions for device software functions. This document replaces FDA's “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices” issued on May 11, 2005. The field of medical devices has seen significant...
Jun 29, 2023
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Challenges in writing Clinical Evaluation Reports
After the implementation of MDR, manufacturers are facing various challenges with the information required for the development of clinical evaluation report. It requires lots of know-how and experience because of rigorous review by the notified bodies. So, before starting the Clinical Evaluation Report, manufacturers need to understand the basic requirements of the following standards and...
Jun 27, 2023
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Investigation and Root cause analysis
Achieving effective root cause analysis involves following a structured approach towards investigation and utilizing various techniques. Effective investigation and root cause analysis are critical processes for identifying the underlying causes of incidents, problems, or failures. By conducting a thorough investigation and determining the root cause, organizations can implement targeted...
Jun 26, 2023
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