A successful and safe medical device development is an essential element of any medical device manufacturer. Developing the right medical device needs repetition of processes to ensure the quality of the device to prevent the future risk of failure of the product. A medical device company strives hard to improve and meet stringent regulatory requirements laid down by governing bodies to contribute to better health by producing a safe and risk-free product. The quality Management System (QMS) during development of a product takes continuous efforts not to commit errors and correct them at the right time.
CORRECTIVE ACTION REQUEST (CAR)
A Corrective Action Request is a change request which states a problem related to the process or the product and requests the correction to the root cause of the nonconformity. CAR is the method of notification of the nonconformity and documentation of the method used to correct it. This process takes place during audits conducted by QMS.
Corrective Action Request is addressed in ISO 13485:2016 in clause 8.5.2 of Corrective Action and Preventive Action (CAPA). The FDA inspection and ISO audits always evaluate CAPA for medical device Quality Management System. A CAR denotes the need for risk assessment, which usually happens when nonconformities occur with suppliers, eventually leading to Supplier Corrective Action Request (SCAR).
Read more – CORRECTIVE ACTION REQUEST (CAR)
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4. Continuous Improvement Program
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7. Manufacturing Plant Layout Design
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16. 21 cfr part 820
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