Medical Device Vendor Audit Checklist

Medical device companies must conduct regular self-audits or internal audits in order to ensure that their documents and quality management system (QMS) conform to regulatory standards.

Preparing for medical device audits can be made simpler with the implementation of a digital QMS for medical devices. Discover how a system with built-in audit workflows can accelerate this process and enhance audit outcomes.

1. Regulatory Requirements
Medical device companies must establish appropriate evaluation processes to evaluate their suppliers. These measures should include purchasing data analysis, verification of products and services purchased, supplier selection process evaluation/reevaluation procedures as well as corrective and preventive action (CAPA) processes.

These procedures should also identify the risk level associated with each supplier and conduct audits or inspections accordingly. The risk level can be assessed based on factors like classification of device as well as any ramifications of noncompliance with regulations or quality requirements.

Suppliers with critical components that directly influence the performance of finished medical devices pose the highest risks, and should be subject to more frequent and extensive audit or inspection processes.

2. Design and Development
Medical device companies that wish to remain ISO 13485 compliant must conduct regular self-audits of their Quality Management System in order to remain compliant. This involves auditing documents as well as physically inspecting their sites.

As well as guaranteeing the quality of final products and services, this process must also involve supplier evaluation and monitoring to verify whether suppliers can produce products that fulfill the intended uses and specifications outlined by your QMS.

Medical devices were once manufactured primarily by their manufacturers; now, manufacturers increasingly outsource production work to medical device vendors who supply key components and services needed for design, prototyping, manufacturing, subassembly and final assembly of medical devices.

3. Manufacturing
Most medical device companies outsource fabrication of key components, like absorbable sutures. Audits are essential in this situation to ensure manufacturing meets ISO and FDA requirements.

Monitoring supplier performance requires vendor scorecards, supplier surveys and verification processes that help a company stay abreast of supplier activity on an ongoing basis according to predetermined metrics.

Special audits should be conducted more frequently on components that pose greater risks to users, including manufacturing process parameters, sterilization process validation results and inspection and test results for finished devices.

4. Quality Control
Faulty defibrillators may fail to deliver lifesaving charges when needed; syringes with internal defects can increase bloodstream infection risk; and medical devices manufactured improperly pose significant safety concerns, so having a robust quality control process in place is vital for any manufacturer of medical devices.

QC activities involve selecting suppliers who consistently produce materials or components that comply with your company’s standards. If any supplier falls below this benchmark, their ability to continue producing product must be carefully assessed before proceeding further with production.

Your company must conduct testing and verification activities that ensure your products comply with intended use specifications, as well as requirements set by regulators. In addition, corrective and preventive actions (CAPA) must be managed, with staff who possess extensive knowledge about medical devices performing evaluations to do this effectively.

5. Purchasing
Medical device manufacturers must implement supplier evaluation and monitoring as part of their internal quality management systems and ISO 13485 compliance requirements.

Your company should prioritize suppliers according to risk. Suppliers ranked as “critical” will require extensive auditing, inspections, verification and vigilance; generally these would include contract manufacturers who assemble medical devices as well as vendors whose services directly impact product safety.

Your medical device manufacturer must also submit third-party audit reports from notified bodies or regulatory authorities on all critical suppliers. Unannounced audits from these same agencies and regulators, especially after 483 observations or warning letters have been issued, can occur and these follow-up inspections are known as compliance follow-up inspections.