Medical device manufacturers can often be challenged in relation to auditor independence and resource requirements when fulfilling their internal audit program. Kinesys can perform all or part of your internal or supplier audit program to meet the requirements of ISO 13485, using auditors that are familiar with notified body auditing techniques such as ISO 17021 and MDSAP.

• Develop an Audit Programme from review of previous audit results, areas of risk and to reflect your wider management system
• Carry out Internal and Supplier Audits with all audit preparation, planning & reporting
• Verification of audit nonconformities, including analysis of data and trending
• Provide feedback into the management review meeting via an audit report
• Audits carried out by IRCA trained and registered Auditors