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ISO 13485 Lead Auditor Certification Training Course

Master advanced ISO 13485 audit principles and compliance frameworks.

Lead end-to-end internal and external medical device audits with confidence.

Gain practical audit expertise through real-world case studies.

Drive corrective actions and continuous improvement initiatives.

Virtual Classroom
Training

Practice Questions
on LMS

Guaranteed to
Run Batches

Experienced
Instructors

Exam
Simulation

Post-Training
Support

Virtual Classroom
Training

Practice Questions
on LMS

Guaranteed to
Run Batches

Experienced
Instructors

Exam
Simulation

Post-Training
Support

ISO 13485 Lead Auditor

✓
Training Material
✓
Hands-On Project Based Learning
✓
Instructor-Led Virtual Classroom Training

Target Audience

Pre-Requisites

Exam Information

FAQ

✓ Auditors seeking to perform and lead Medical Devices Quality Management System (MDQMS) certification audits

✓ Managers or consultants seeking to master a Medical Devices Quality Management System audit process

✓ Individuals responsible for maintaining conformance with Medical Devices Quality Management System requirements

✓ Technical experts seeking to prepare for a Medical Devices Quality Management System audit

✓ Expert advisors in Medical Devices Quality Management

✓ A fundamental understanding of ISO 13485 and comprehensive knowledge of audit principles.

✓ The “PECB Certified ISO 13485 Lead Auditor” exam fully meets the requirements of the PECB Examination and Certification Programme (ECP). The exam covers the following competency domains:

✓ Domain 1: Fundamental principles and concepts of a Medical Devices Quality Management System (MDQMS)

✓ Domain 2: Medical Devices Quality Management System (MDQMS)

✓ Domain 3: Fundamental audit concepts and principles

✓ Domain 4: Preparation of an ISO 13485 audit

✓ Domain 5: Conducting an ISO 13485 audit

✓ Domain 6: Closing an ISO 13485 audit

✓ Domain 7: Managing an ISO 13485 audit program

✓ For specific information about the exam type, languages available, and other details, please visit the List of PECB Exams and the Examination Rules and Policies.

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Frequently Asked Questions

🔹What is ISO 13485 Lead Auditor Certification?

ISO 13485 Lead Auditor Certification validates a professional’s ability to plan, conduct, manage, and report audits of Medical Device Quality Management Systems (MDQMS) in accordance with ISO 13485 standards and regulatory requirements.

🔹 Who should take ISO 13485 Lead Auditor Training?

This certification is ideal for:

• Quality Managers and QA Professionals

• Regulatory Affairs Specialists

• Compliance Officers

• Internal Auditors

• Consultants in the medical device industry

🔹 What are the prerequisites for ISO 13485 Lead Auditor?

While prior knowledge of ISO 13485 and QMS concepts is recommended, there are typically no mandatory prerequisites. Basic understanding of medical device regulations enhances learning outcomes.

🔹 What will you learn in ISO 13485 Lead Auditor Training?

Participants learn to:

• Interpret ISO 13485 requirements

• Apply risk-based audit methodologies

• Conduct first, second, and third-party audits

• Identify nonconformities and recommend corrective actions

• Lead audit teams effectively

🔹 What is the career scope after ISO 13485 Lead Auditor Certification?

Certified professionals can pursue roles such as:

• ISO 13485 Lead Auditor

• Medical Device Compliance Manager

• QMS Consultant

• Regulatory Audit Specialist

This certification significantly enhances global employability and leadership positioning in the medical device sector.

🔹 How much does ISO 13485 Lead Auditor Certification cost?

The cost varies depending on the training provider, delivery mode (online/classroom). Typically, it includes training, study material, and examination fees.

🔹 How long is ISO 13485 Lead Auditor valid?

Certification validity depends on the issuing body. Many require periodic professional development or re-certification to maintain credential status.