Our Services

Medical device auditing

The medical device manufacturer must manufacture safe and effective products to diagnose and/or treat diseases. Industry as well as regulatory requirements are on the increase as standards organizations regulatory bodies, and users & patients expect ever more safety and effectiveness. The global quality management system standard for medical devices is ISO 13485. QA1 provides support to manufacturers and sellers of medical devices to implement the latest version of ISO 13485 using supplier/vendor management and external third-party ISO 13485 audits. Our ISO 13485 audit services are based on facts and are performed by our certified competent auditors. These auditors have done a large number of supplier audits right from initial approval to maintenance.

Medical device auditing

The medical device manufacturer must manufacture safe and effective products to diagnose and/or treat diseases. Industry as well as regulatory requirements are on the increase as standards organizations regulatory bodies, and users & patients expect ever more safety and effectiveness. The global quality management system standard for medical devices is ISO 13485. QA1 provides support to manufacturers and sellers of medical devices to implement the latest version of ISO 13485 using supplier/vendor management and external third-party ISO 13485 audits. Our ISO 13485 audit services are based on facts and are performed by our certified competent auditors. These auditors have done a large number of supplier audits right from initial approval to maintenance.

Medical device auditing

The medical device manufacturer must manufacture safe and effective products to diagnose and/or treat diseases. Industry as well as regulatory requirements are on the increase as standards organizations regulatory bodies, and users & patients expect ever more safety and effectiveness. The global quality management system standard for medical devices is ISO 13485. QA1 provides support to manufacturers and sellers of medical devices to implement the latest version of ISO 13485 using supplier/vendor management and external third-party ISO 13485 audits. Our ISO 13485 audit services are based on facts and are performed by our certified competent auditors. These auditors have done a large number of supplier audits right from initial approval to maintenance.