Medical Device Manufacturer Audit
Medical device manufacturers are required to produce safe and effective products for diagnosing and treating diseases. As industry and regulatory requirements continue to evolve, standards organizations, regulatory bodies, and users—including patients—demand higher levels of safety and effectiveness. The global quality management system standard for medical devices is ISO 13485.
At QA1, we support manufacturers and sellers of medical devices in implementing the latest version of ISO 13485 through comprehensive supplier/vendor management and external third-party audits. Our ISO 13485 audit services are fact-based and conducted by our certified auditors, who have extensive experience performing supplier audits from initial approval through ongoing maintenance.
