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ISO 13485 Foundation Certification Training Course

Build strong fundamentals of ISO 13485 and Medical Device Quality Management Systems.

Receive structured exam preparation with expert guidance.

Ideal for quality, regulatory, and compliance professionals.

Strengthen your professional credibility with globally recognized certification.

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 Foundation

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

Target Audience

Pre-Requisites

Exam Information

FAQ

✓ Individuals involved in Medical Devices Quality Management

✓ Individuals seeking to gain knowledge about the main processes of Medical Devices Quality Management Systems (MDQMS)

✓ Individuals interested to pursue a career in Medical Devices Quality Management

✓ There are no prerequisites required for ISO 13485 Foundation training.

The exam fully meets the requirements of the PECB Examination and Certificate Programme. It 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)

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

Want to Train Your Team?

Corporate Training Solutions

Help your teams grow with personalized training programs and affordable pricing that fit your business goals. Build a future-ready workforce by boosting digital skills, technical know-how, and a mindset of continuous improvement.

✓ Scalable Learning Programs for Teams of Any Size

✓ Dedicated Customer Success Manager & Post-Training Support

✓ Cost-Effective Exam Voucher Packages.

Frequently Asked Questions

🔹What is ISO 13485?

ISO 13485 training is a professional program that teaches the requirements of a Medical Devices Quality Management System (QMS) based on the international standard published by International Organization for Standardization. It helps professionals understand regulatory compliance, risk management, documentation, and quality control in the medical device industry.

🔹What are the benefits of taking this ISO 13485 Course?

Iso 13485 Foundation Course enhances your understanding of ISO 13485 standards, improves your ability to implement and maintain a compliant QMS, and boosts your career prospects in the medical device industry.

🔹Are there any prerequisites to attend this ISO 13485 Training?

There are no specific prerequisites for attending the course, but a basic understanding of quality management systems or the medical device industry can be helpful.

🔹Who should attend this ISO 13485 Course?

ISO 13485 training is ideal for:

Quality Assurance and Quality Control professionals
Regulatory Affairs managers
Medical device manufacturers
QMS consultants
Production and operations leaders
Professionals entering the medical device sector

🔹What is included in this ISO 13485 Course?

The course includes expert-led training sessions, comprehensive study materials, case studies, and practical exercises to provide a thorough understanding of ISO 13485 requirements and implementation.

🔹What is the duration of this ISO 13485 Training?

ISO 13485 Foundation Training takes 1-day to complete during which delegates participate in intensive learning sessions that cover various course topics.

🔹Is there an examination for this ISO 13485 Training Course?

Yes, many ISO 13485 courses include an assessment to evaluate your understanding. Successful completion may lead to certification.

🔹What kind of jobs can I expect based on this ISO 13485 Foundation Training Course?

This training prepares you for roles such as Quality Assurance Manager, Regulatory Compliance Officer, Internal Auditor, and QMS Consultant in the medical device sector.

🔹What are the best ISO 13485 Training courses in India?

Please see our ISO 13485 Training courses available in India.

🔹What is the difference between ISO 13485 Foundation and Lead Auditor training?

The Foundation course provides basic knowledge of the standard, while the Lead Auditor course focuses on auditing techniques, audit planning, reporting, and leading audit teams.

🔹How do I enroll in ISO 13485 training at Knowlathon?

You can enroll through Knowlathon’s official website or contact the admissions team for batch schedules, corporate training options, and pricing details.