Makrocare
Member
MakroCare provides expert QMS Vendor Auditor services for medical device manufacturers, facilitating comprehensive audits of Contract Research Organizations (CROs) to ensure compliance with quality management system (QMS) requirements. With a focus on regulatory adherence and operational excellence, our specialized auditing team delivers thorough assessments to enhance vendor performance and mitigate risks in outsourced activities.
Our QMS Vendor Auditor service encompasses detailed evaluation of CROs' quality management systems, procedures, and practices against regulatory standards such as ISO 13485, FDA Quality System Regulation (QSR), and applicable guidelines. We conduct onsite and remote audits, leveraging our industry expertise to identify areas of non-compliance, process gaps, and potential risks.
for more info: https://www.makrocare.com/devices/audits/
Our QMS Vendor Auditor service encompasses detailed evaluation of CROs' quality management systems, procedures, and practices against regulatory standards such as ISO 13485, FDA Quality System Regulation (QSR), and applicable guidelines. We conduct onsite and remote audits, leveraging our industry expertise to identify areas of non-compliance, process gaps, and potential risks.
for more info: https://www.makrocare.com/devices/audits/
