Medical Device Non-Conformance
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Do You Have a Medical Device Non-Conformance?
A robust Quality Management System should accurately identify and address non-conformances, ultimately preventing their occurrence and improving the overall quality of your medical devices.
It is essential for a medical device manufacturer to effectively manage non-conformances to ensure patient safety and regulatory compliance and protect their reputation.
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Failing to Manage Your Non-Conformances Effectively
Non-conformances occur when a product or process does not meet regulatory requirements, quality standards, or approved in-house procedures. Failure to effectively manage non-conformances may jeopardise your CE UKCA marking status, lead to higher business costs, penalties from regulatory authorities, and even medical device recalls.
This can negatively impact your Quality Management System and raise concerns about patient safety, ultimately leading to a decline in the quality of care. This is why managing and reporting non-conformances in real-time is crucial.
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The Process of Non-Conformance Management in Medical Devices
The management of non-conformances in medical devices involves several steps. These include identification, investigation, Root Cause Analysis (RCA), impact assessment, and planning Corrective and Preventive Action(s) (CAPA).
It is important that the process is well-documented and that all stakeholders are trained in the process to ensure its effectiveness.
This involves implementing measures to correct the issue and verifying the effectiveness of these measures through testing and monitoring of potential risks.
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- Identification
This can be accomplished through various methods, such as internal audits, customer complaints, or routine inspections across all operations and shifts.
- Investigation
This involves gathering information about the non-conformance, analysing data and identifying the underlying problem.
- Evaluation
Once the root cause of the non-conformance is identified, the impact on patient safety and the medical device’s regulatory compliance must be evaluated.
- CAPA
This involves implementing measures to correct the issue and verifying the effectiveness of these measures through testing and monitoring of potential risks.
If you are a medical device manufacturer in need of immediate support and guidance with non-conformances, CAPA management, product recalls, or in-market incidents, we have the expertise to assist you in real time.
Contact us today at +44 (0)1452 341913 or enquiries@qaeclimited.co.uk, and we will provide you with the guidance and support you need.
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