Certificate Programme in ISO 13485:2016 Medical Devices Auditor Training
-- viewing nowThe ISO 13485:2016 Medical Devices Auditor Training is designed for professionals responsible for ensuring the quality of medical devices. Developed for medical device auditors and quality managers, this programme provides comprehensive knowledge of the ISO 13485:2016 standard.
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About this course
Through interactive sessions and case studies, learners will gain a deep understanding of the standard's requirements and auditing techniques.
Some key topics covered include risk management, quality management systems, and regulatory compliance.
By the end of the programme, learners will be equipped to conduct effective audits and ensure medical device manufacturers meet the required standards.
Don't miss this opportunity to enhance your skills and knowledge. Explore the Certificate Programme in ISO 13485:2016 Medical Devices Auditor Training today and take the first step towards becoming a certified medical device auditor.
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Course details
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Quality Management System (QMS) Overview - This unit introduces the fundamental principles of ISO 13485:2016, including the importance of a QMS in medical device manufacturing and the role of the auditor in ensuring compliance. •
Medical Device Lifecycle Management - This unit covers the entire lifecycle of a medical device, from design and development to production, distribution, and post-market surveillance, highlighting the need for a QMS that addresses each stage. •
Risk Management and Failure Mode and Effects Analysis (FMEA) - This unit focuses on the risk management process, including FMEA, to identify and mitigate potential risks associated with medical devices, ensuring the QMS is effective in managing these risks. •
Document Control and Change Management - This unit emphasizes the importance of document control and change management in the QMS, including the use of controlled documents, version control, and the management of changes to the QMS. •
Training and Awareness - This unit highlights the need for regular training and awareness programs to ensure that personnel involved in the QMS are competent and aware of their roles and responsibilities. •
Internal Audits and Management Review - This unit covers the internal audit process, including planning, conducting, and reporting on audits, as well as the management review process to ensure the QMS is effective and aligned with the organization's objectives. •
Continuous Improvement and Corrective Action - This unit focuses on the importance of continuous improvement and corrective action in the QMS, including the use of lessons learned and near misses to drive improvement and prevent future errors. •
Medical Device Regulation and Compliance - This unit covers the regulatory requirements for medical devices, including the EU MDR, FDA regulations, and other national regulations, highlighting the need for the QMS to ensure compliance with these regulations. •
Medical Device Software as a Medical Device (SaMD) and Medical Device Data Synthesis (MDDS) - This unit addresses the specific requirements for medical device software and data synthesis, including the need for a QMS that addresses these emerging technologies. •
ISO 13485:2016 Auditor Competence and Awareness - This unit emphasizes the importance of auditor competence and awareness in ensuring the QMS is effective and compliant with the requirements of ISO 13485:2016.
Quality Management System (QMS) Overview - This unit introduces the fundamental principles of ISO 13485:2016, including the importance of a QMS in medical device manufacturing and the role of the auditor in ensuring compliance. •
Medical Device Lifecycle Management - This unit covers the entire lifecycle of a medical device, from design and development to production, distribution, and post-market surveillance, highlighting the need for a QMS that addresses each stage. •
Risk Management and Failure Mode and Effects Analysis (FMEA) - This unit focuses on the risk management process, including FMEA, to identify and mitigate potential risks associated with medical devices, ensuring the QMS is effective in managing these risks. •
Document Control and Change Management - This unit emphasizes the importance of document control and change management in the QMS, including the use of controlled documents, version control, and the management of changes to the QMS. •
Training and Awareness - This unit highlights the need for regular training and awareness programs to ensure that personnel involved in the QMS are competent and aware of their roles and responsibilities. •
Internal Audits and Management Review - This unit covers the internal audit process, including planning, conducting, and reporting on audits, as well as the management review process to ensure the QMS is effective and aligned with the organization's objectives. •
Continuous Improvement and Corrective Action - This unit focuses on the importance of continuous improvement and corrective action in the QMS, including the use of lessons learned and near misses to drive improvement and prevent future errors. •
Medical Device Regulation and Compliance - This unit covers the regulatory requirements for medical devices, including the EU MDR, FDA regulations, and other national regulations, highlighting the need for the QMS to ensure compliance with these regulations. •
Medical Device Software as a Medical Device (SaMD) and Medical Device Data Synthesis (MDDS) - This unit addresses the specific requirements for medical device software and data synthesis, including the need for a QMS that addresses these emerging technologies. •
ISO 13485:2016 Auditor Competence and Awareness - This unit emphasizes the importance of auditor competence and awareness in ensuring the QMS is effective and compliant with the requirements of ISO 13485:2016.
Career path
Certificate Programme in ISO 13485:2016 Medical Devices Auditor Training
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Career Roles and Job Descriptions
Medical Devices Auditor
Conduct audits to ensure medical devices meet regulatory requirements and industry standards. Ensure compliance with ISO 13485:2016 and other relevant regulations.
Quality Manager
Oversee quality management systems to ensure medical devices meet regulatory requirements and industry standards. Develop and implement quality policies and procedures.
Regulatory Affairs Specialist
Ensure medical devices comply with regulatory requirements and industry standards. Prepare and submit regulatory documents, such as 510(k) submissions.
Medical Device Engineer
Design, develop, and test medical devices to ensure they meet regulatory requirements and industry standards. Collaborate with cross-functional teams to ensure device quality and compliance.
Clinical Research Coordinator
Coordinate clinical trials to ensure medical devices meet regulatory requirements and industry standards. Manage clinical trial data and ensure compliance with Good Clinical Practice (GCP) guidelines.
Entry requirements
- Basic understanding of the subject matter
- Proficiency in English language
- Computer and internet access
- Basic computer skills
- Dedication to complete the course
No prior formal qualifications required. Course designed for accessibility.
Course status
This course provides practical knowledge and skills for professional development. It is:
- Not accredited by a recognized body
- Not regulated by an authorized institution
- Complementary to formal qualifications
You'll receive a certificate of completion upon successfully finishing the course.
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CERTIFICATE PROGRAMME IN ISO 13485:2016 MEDICAL DEVICES AUDITOR TRAINING
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