Regulatory bodies such as the ISO and the FDA frequently evaluate laboratory operations to check compliance. Because laboratories guarantee quality in medical device and pharmaceutical companies’ operations, any non-conformance in the laboratory can mean...
Being a medical devices company, you are well aware of the fact that your products must be made to the highest standards and serve their intended purpose. Let us take the example of absorbable sutures, a Class III medical device, which your company manufactures and...
CAPA reports are critical in every regulatory inspection for medical devices, pharmaceuticals, and other life science companies worldwide including the EU and the US. They must be accurately written and should provide the auditors the information about the CAPA...
ISO 13485 audit provides an objective measure of the organizations’ processes and regulatory compliance with the latest ISO 13485:2016 standard. Let us say that you are a medical device manufacturer based in the US. You, therefore, need to be compliant with FDA rules...
Corrective and preventive action (CAPA) procedures are critical to the success of the quality management system (QMS) and CAPA sub-system in any life science organization. A poorly written or implemented CAPA procedure can lead to failed corrective and preventive...
