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Understand the purpose of a medical device quality management system (MD-QMS), interaction with appropriate medical device regulatory authority requirements, quality management systems standards, third-party certification, and the business benefits of the quality management system.
Understand the role and responsibilities of an auditor to plan, conduct, report, and follow-up a quality management system audit in accordance with ISO 19011 and ISO/IEC 17021. Learn to plan, conduct, report, and follow-up an audit of a medical device quality management system to establish conformity (or otherwise) with ISO 13485 and applicable medical device regulatory requirement documents.
ISO 13485:2016 is the international standard that specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.
ISO 13485:2016 Certification is applicable to organizations involved in the medical device industry, including manufacturers, suppliers, and service providers.
Documents are grouped the way certification bodies review them — business documents, quality management documents, and medical device records.
Each stage is a real, sequential step through the ISO 13485:2016 Certification process under the International Organization for Standardization.
Get in touch with our experts to discuss your ISO 13485:2016 Certification requirements and medical device business type.
Conduct a comprehensive gap analysis to identify deviations from ISO 13485:2016 requirements.
Update and develop all required documentation (Quality Manual, procedures, and records) to meet the standards.
Roll out and implement the QMS across the organization. Train employees on new QMS processes.
Perform internal audits to assess compliance, identifying and addressing any discrepancies. Implement CAPA for identified non-conformities.
Engage a certification body to perform the external certification audit and verify compliance with ISO 13485:2016.
Upon successful audit, we receive the ISO 13485:2016 Certificate and send a copy to you via email or courier.
ISO 13485:2016 Certification is typically valid for a period of 3 years. To maintain the certification, organizations must:
We manage every step, document, and follow-up with the certification body so you can focus on your medical device business.
We assess your current quality management practices against ISO 13485:2016 requirements.
Complete Quality Manual, SOPs, and documentation drafting as per ISO 13485:2016 standards.
Assistance in implementing QMS and training employees on new medical device quality processes.
Conduct internal audits, identify non-conformities, and implement CAPA for readiness.
Complete ISO 13485:2016 application filing with the accredited certification body.
We respond to all queries from the certification body on your behalf.
A full compliance schedule including surveillance audits and recertification reminders.
Talk to a First Auditor specialist today — get a clear fee quote and document checklist before you start.
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