April 5, 2021 | Barb Carr

Medical Device: Root Cause Analysis

The aim of root cause analysis in the medical device manufacturing sector, along with any part of a quality and regulatory system is to produce safer, more effective treatment options for doctors, hospitals, and ultimately for patients. TapRooT® Root Cause Analysis creates an opportunity to make improvements and prevent incidents/ failures.

Quality in Medical Device Manufacturing

Incidents that lead to the need for corrective actions or CAPA can be used to investigate, find, and fix issues using TapRooT® Root Cause Analysis tools and training. These incidents can be obtained by utilizing complaints, audits, and non-conformances from your quality systems. In fact, you can utilize TapRooT® for your audits. Utilizing TapRooT® proactively can remove the headache of interactions with regulatory agencies.

We are able to train your employees on how to utilize TapRooT® Root Cause Analysis for incident investigations and auditing in our on-site and public courses.

Root cause analysis is an important part of your investigations process when manufacturing medical devices because identifying your root cause(s) allows you to rectify at the source of the problem and prevent occurrences. The regulations process that surround the medical device manufacturing industry includes a strict adherence to regulatory compliance. With increased scrutiny from the FDA and other regulatory agencies, it is important for medical device manufacturing companies to implement a proven system to prevent mistakes, errors, and failures.

TapRooT® Root Cause Analysis is the world’s leading system, analysis process, training, & software to analyze and fix problems real root causes.

Patient Safety & Healthcare, Quality, Root Cause Analysis
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