The Medical Device Single Audit Program (MDSAP) is a program that allows the conduct of a single regulatory audit of a medical device manufacturer that satisfies the relevant requirements of multiple regulatory authorities. Audits are conducted by Auditing...
Quality audits are crucial to ensure compliance with regulatory requirements in any industry. Similarly, quality audits are conducted in the pharmaceutical industry to ensure that the complex system of processes and operations of your pharmaceutical company meets...
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...
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...
Remote audits offer an indispensable tool for improving and verifying medical device, pharmaceutical, and other life science organization’s compliance with the specific standards. Especially amongst the current travel restrictions due to the pandemic. Although,...
