Training Features

ISO 13485: The Global Quality Management Systems Standard for Medical Devices

Learn how ISO 13485 defines the global requirements for building, implementing, and maintaining an effective quality management system for medical devices across the entire product lifecycle.
Format

E-Learning

Level

Intermediate

Trainer

René Schings

Exam

Exam and certificate included

Duration

5 hours
21 modules

Price

€ 645 or equivalent currency

Mastering ISO 13485: The Engine of Quality and Patient Safety

In an industry where precision saves lives, our QMS is more than just a set of documents—it is a proactive commitment to excellence. Throughout this e-learning, you will explore how to harness objective data, manage real-world feedback, and drive the continuous improvements necessary to ensure that every device reaching a patient is safe, effective, and fully compliant.
What You Will Learn
Who Should Attend?
What is Included?
Course Details
  • Global Regulatory Context: Understand the landscape of worldwide medical device regulations and how ISO 13485 serves as the universal foundation for establishing a compliant Quality Management System (QMS).
  • The Mission of Safety and Performance: Recognize that the primary purpose of a QMS is to ensure the ongoing safety and efficacy of devices for patients and users, while acknowledging that device definitions may vary across different global regions.
  • Core QMS Framework and Responsibilities: Master the structure of ISO 13485, specifically the requirements for documented records, management oversight, and the strategic allocation of resources.
  • The Product Lifecycle and Improvement Loop: Gain the ability to locate and apply requirements for the entire device lifecycle—from initial order and realization to delivery—and understand how market feedback and monitoring drive systemic improvements.
  • Individual Impact and Audit Readiness: Internalize how your specific role contributes to overall compliance and patient safety, providing the insight needed to navigate audits and inspections with confidence.
Please note that throughout this training, the term "Medical Device (MD)" is used inclusively to represent "In Vitro Diagnostic Device (IVD)." While some regions apply distinct definitions and regulatory frameworks to these categories, the quality management principles discussed here apply equally to both.
What is included in this e-learning?
  • Access to the Qserve Learn Training Portal
  • A training certificate upon completion of the training.
Access to any mentioned guidances or ISO standards that are not publicly available is not included in this e-learning.
  • Duration: Approx. 4 hours to complete.
  • Format: Self-paced e-learning (video, interactive content, and quizzes).
The training is intended for:
  • Quality (QA) and Regulatory (RA) professionals new to the field. 
  • Staff in functions affected by a Quality Management System.
  • Anybody involved in setting up a new Quality Management System (QMS) according to either ISO13485 or the US QMSR. 
  • Senior and middle Management and supervisors (in the medical device industry). 
  • Design and development staff.
  • Suppliers to and (sub)contractors for medical device companies.
The course is not intended to provide an in-depth or line-by-line analysis and explanation of the ISO 13485 standard.

Comprehensive Regulatory Expertise

Advance your career by mastering the standards that define global medical device compliance, all through a flexible learning schedule.
Upon successful completion of the program, participants receive a recognized certification, boosting their career prospects and demonstrating their expertise to employers and clients.

Certification and Career Advancement

We offer a flexible learning schedule, allowing professionals to balance their training with their busy work and personal lives, ensuring accessibility to a wide range of learners.

Flexible Learning Schedule

Modules

Explore the training modules available in this course

Meet the Trainer

René Schings

René, with over 20 years of management experience in Quality Management, Research & Development, and more, serves as a lead auditor at Qserve, specializing in ISO audits, and brings expertise in building QMS for start-ups, managing complex change projects, and overseeing multi-site, multi-cultural teams, having previously held senior positions in the Medical Device and Consumer Electronics industries.
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