ISO 13485 Training

About ISO 13485 Training

In the dynamic realm of medical device quality management, excelling in your career requires staying ahead of industry standards. Integrated Assessment Services (IAS) offers ISO 13485 Training, meticulously designed to equip individuals with the necessary skills and knowledge to lead and conduct successful audits in accordance with the international standard for medical device quality management systems.

CQI and IRCA Certification

CQI-IRCA Accredited ISO 13485 Training

In collaboration with Empowering Assurance Systems (EAS), IAS provides CQI-IRCA Accredited ISO 13485 Training for those dedicated to auditing medical device quality management systems. This comprehensive training program covers essential aspects, including:

  • Review of the ISO 13485 Standard
  • Auditor Roles and Responsibilities
  • Audit Planning, Conducting, and Reporting
  • Nonconformity Identification and Reporting
  • Evaluating Corrective Action Proposals

Course Deliverables for ISO 13485 Training

Our ISO 13485 Training goes beyond conventional methods to deliver a dynamic and thorough learning experience. Participants can expect a range of valuable deliverables designed to enhance their understanding and application of medical device quality management principles:

Interactive Activities: Engage in an energetic learning environment with activities that promote participation and collaboration. These activities deepen understanding of ISO 13485 concepts and encourage active involvement.

Exercises: Enhance your practical skills through hands-on exercises simulating real-world scenarios. These exercises allow you to apply theoretical knowledge to practical situations, preparing you for auditing challenges within a medical device manufacturing context.

Quizzes: Periodic quizzes assess your grasp of key concepts, serving as self-assessment tools to gauge progress, identify areas for improvement, and reinforce your understanding of ISO 13485 requirements.

Case Studies: Explore real-world applications of ISO 13485 through case studies. These scenarios provide insights into practical challenges faced in medical device quality management and offer opportunities to analyze and apply learned principles to resolve complex situations.

Downloadable Course Material: Access a wealth of resources at your fingertips with downloadable course materials. These materials include additional readings, reference documents, and supplementary content that serve as valuable references for post-training review and ongoing professional development.

ISO 13485 Standard Copy: Receive a copy of the ISO 13485 standard, providing you with the foundational document to refer to during and after the training. Having direct access to the standard allows you to navigate and understand the requirements, facilitating a deeper comprehension of ISO 13485 principles.

Who Should Attend ISO 13485 Training?

This ISO 13485 lead auditor training program is tailored for professionals involved in medical device manufacturing, quality assurance, and those aspiring to become lead auditors. Whether you are from a medical device company, regulatory body, or research institution, our ISO 13485

training will equip you with the skills needed to ensure compliance and excellence in your organization.

ISO 13485 Training Delivery Methods

IAS provides ISO 13485 training through various methods to accommodate diverse learning preferences and organizational needs. Throughout this 5-day, 40-hour program, candidates can choose the method of delivery that suits them:

In-House ISO 13485 Training: Customize the training content to address specific organizational processes, challenges, and industry requirements. Foster team cohesion and ensure a shared understanding of ISO 13485 standards without the need for travel.

Open Classroom ISO 13485 Training: Engage with professionals from various industries in a centralized training program. Benefit from a standardized curriculum and diverse perspectives, making it suitable for individuals or smaller teams.

Tutor-Led Virtual ISO 13485 Training: Join training sessions remotely from anywhere with an internet connection. Enjoy interactive learning with elements like virtual breakout sessions and discussions. This flexible option reduces travel-related expenses.

Check out our ISO 13485 Training Schedule to view upcoming course dates!


Enroll in our ISO 13485 Training program to invest in your professional development and contribute to the success of your organization. Stay at the forefront of industry standards, boost your career prospects, and play a pivotal role in enhancing the quality and credibility of your medical device manufacturing processes.

Join us on this journey towards excellence in quality management for medical devices. Take the next step in your career by attending ISO 13485 Training with IAS. Elevate your expertise and make a lasting impact in the world of medical device quality management. Contact us today!