Professional Certificate in ISO 13485:2016 Medical Devices Quality Auditor Training
-- viewing nowISO 13485:2016 Medical Devices Quality Auditor Training Develop the skills to audit medical devices quality systems with our Professional Certificate in ISO 13485:2016. This training is designed for quality professionals, auditors, and regulatory experts who want to ensure medical devices meet international standards.
3,946+
Students enrolled
GBP £ 149
GBP £ 215
Save 44% with our special offer
About this course
Understand the requirements of ISO 13485:2016 and learn to conduct effective audits to identify non-conformities and areas for improvement.
Gain knowledge of medical devices quality management systems, risk management, and continuous improvement.
Prepare for audits and assessments with our expert instructors and real-world case studies.
Take the first step towards a career in medical devices quality assurance. Explore our course today and start your journey to becoming a certified ISO 13485:2016 Medical Devices Quality Auditor.
100% online
Learn from anywhere
Shareable certificate
Add to your LinkedIn profile
2 months to complete
at 2-3 hours a week
Start anytime
No waiting period
Course details
•
Quality Management System (QMS) Overview - This unit introduces the fundamental principles of ISO 13485:2016, including the medical devices industry context, quality policy, and quality objectives. •
Medical Devices Regulations and Standards - This unit covers the regulatory requirements for medical devices, including EU MDR, FDA regulations, and other national standards, ensuring a comprehensive understanding of the regulatory landscape. •
Risk Management and Failure Mode and Effects Analysis (FMEA) - This unit focuses on risk management techniques, including FMEA, to identify and mitigate potential risks associated with medical devices, ensuring a safe and effective QMS. •
Document Control and Change Management - This unit emphasizes the importance of document control and change management in maintaining a QMS, including procedures for document creation, review, approval, and implementation. •
Training and Awareness - This unit highlights the significance of employee training and awareness in ensuring a QMS is effective, including training programs for employees, management, and external auditors. •
Internal Audits and Continuous Improvement - This unit covers the principles of internal audits, including audit planning, conduct, and reporting, as well as the importance of continuous improvement in maintaining a QMS. •
Management Review and Corrective Action - This unit focuses on the management review process, including the identification of non-conformities, corrective actions, and preventive actions, ensuring a QMS is effective and efficient. •
Quality System Certification and Auditing - This unit covers the process of obtaining and maintaining ISO 13485:2016 certification, including the auditing process, including audit planning, conduct, and reporting. •
Medical Devices Lifecycle Management - This unit emphasizes the importance of managing medical devices throughout their lifecycle, including design, development, production, and post-market surveillance. •
Medical Devices and Medical Technology Regulation - This unit covers the regulatory requirements for medical devices and medical technology, including EU MDR, FDA regulations, and other national standards, ensuring a comprehensive understanding of the regulatory landscape.
Quality Management System (QMS) Overview - This unit introduces the fundamental principles of ISO 13485:2016, including the medical devices industry context, quality policy, and quality objectives. •
Medical Devices Regulations and Standards - This unit covers the regulatory requirements for medical devices, including EU MDR, FDA regulations, and other national standards, ensuring a comprehensive understanding of the regulatory landscape. •
Risk Management and Failure Mode and Effects Analysis (FMEA) - This unit focuses on risk management techniques, including FMEA, to identify and mitigate potential risks associated with medical devices, ensuring a safe and effective QMS. •
Document Control and Change Management - This unit emphasizes the importance of document control and change management in maintaining a QMS, including procedures for document creation, review, approval, and implementation. •
Training and Awareness - This unit highlights the significance of employee training and awareness in ensuring a QMS is effective, including training programs for employees, management, and external auditors. •
Internal Audits and Continuous Improvement - This unit covers the principles of internal audits, including audit planning, conduct, and reporting, as well as the importance of continuous improvement in maintaining a QMS. •
Management Review and Corrective Action - This unit focuses on the management review process, including the identification of non-conformities, corrective actions, and preventive actions, ensuring a QMS is effective and efficient. •
Quality System Certification and Auditing - This unit covers the process of obtaining and maintaining ISO 13485:2016 certification, including the auditing process, including audit planning, conduct, and reporting. •
Medical Devices Lifecycle Management - This unit emphasizes the importance of managing medical devices throughout their lifecycle, including design, development, production, and post-market surveillance. •
Medical Devices and Medical Technology Regulation - This unit covers the regulatory requirements for medical devices and medical technology, including EU MDR, FDA regulations, and other national standards, ensuring a comprehensive understanding of the regulatory landscape.
Career path
Professional Certificate in ISO 13485:2016 Medical Devices Quality Auditor Training
Job Market Trends and Statistics
Salary Ranges in the UK
Quality Auditor
Conduct audits to ensure medical devices meet regulatory requirements, identify areas for improvement, and implement corrective actions.
Medical Device Auditor
Evaluate medical devices for compliance with regulatory standards, identify potential risks, and provide recommendations for improvement.
Regulatory Compliance Specialist
Develop and implement regulatory compliance strategies, ensure adherence to industry standards, and provide training to staff.
Quality Manager
Oversee quality management systems, develop quality policies, and ensure continuous improvement of quality processes.
Key Skills and Qualifications
Quality Auditor
- ISO 13485:2016 certification
- Medical device industry knowledge
- Auditing and quality management skills
- Communication and interpersonal skills
Medical Device Auditor
- Medical device industry knowledge
- Regulatory compliance expertise
- Auditing and quality management skills
- Analytical and problem-solving skills
Regulatory Compliance Specialist
- Regulatory compliance expertise
- Medical device industry knowledge
- Strategic planning and implementation skills
- Communication and interpersonal skills
Quality Manager
- Quality management system certification (e.g. ISO 9001)
- Medical device industry knowledge
- Leadership and management skills
- Strategic planning and implementation skills
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.
Why people choose us for their career
Loading reviews...
Frequently Asked Questions
Debug: False
Course fee
MOST POPULAR
Fast Track
GBP £149
Complete in 1 month
Accelerated Learning Path
- 3-4 hours per week
- Early certificate delivery
- Open enrollment - start anytime
Standard Mode
GBP £99
Complete in 2 months
Flexible Learning Pace
- 2-3 hours per week
- Regular certificate delivery
- Open enrollment - start anytime
What's included in both plans:
- Full course access
- Digital certificate
- Course materials
All-Inclusive Pricing • No hidden fees or additional costs
Get course information
Earn a career certificate
PROFESSIONAL CERTIFICATE IN ISO 13485:2016 MEDICAL DEVICES QUALITY AUDITOR TRAINING
is awarded to
Learner Name
who has completed a programme at
London School of Planning and Management (LSPM)
Awarded on
05 May 2025
Blockchain Id: s-1-a-2-m-3-p-4-l-5-e
Add this credential to your LinkedIn profile, resume, or CV. Share it on social media and in your performance review.
