ISO 13485:2016 Requirements

ISO 13485:2016 Requirements - 2-day Virtual Classroom Training; May 12-13, 2026.

Schedule (Eastern Time): 9:00 am - 5:00 pm

About the training

With over one million certified companies over the world, the international Quality Management System standard ISO 13485 is among the most commonly used. Since its first publication in 1993, several revisions have taken place aligning the standard with the evolution of the industry and the market needs. The latest edition of ISO 13485 standard for the Medical Device Industry, ISO 13485:2016, was officially published on February 25th, 2016. Medical Device manufactures have yet to understand the changes involved to undertake a smooth transition of their QMS and maintain compliance.

GMED North America’s “ISO 13485:2016 Requirements” training course will provide the attendee with a general understanding of the concepts of the ISO 13485:2016 standard and how the requirements impact the day-to-day operations of organizations in the Medical Device industry. You will learn about the clauses of ISO 13485:2016 in detail, and also participate in group exercises and in-depth discussions.

Attendees successfully completing this course receive a Certification of Completion from GMED North America.

Sign up today and join our intensive 2-day course on the ISO 13485:2016 Requirements.

Acquire a solid foundation so that you and your team are prepared to tackle through practical cases, working sessions, discussions with our expert trainer, and the challenges of the standard.

REQUIRED LEVEL

A prior review of the ISO 13485:2016 standard is recommended for this course.

Who Should Attend:

• Medical Device Manufacturers: Regulatory Affairs Managers, Quality Managers, Person in Charge of Regulatory Compliance
• Internal and External Auditors
• ISO Coordinators/Management Representatives
• Any individual requiring a working knowledge and understanding of ISO 13485:2016 standard

Learning Objectives:

• Describe the new concepts and definitions introduced by ISO 13485:2016
• Learn the key changes and regulatory requirements introduced in the 2016 version of ISO 13485
• Understand the importance of gap assessment and transition timelines
• Cross-referencing between the former versions of ISO 13485 ( ISO 13485:2003 and NF EN ISO 13485:2012) and ISO 13485:2016 for a smooth transition

Educational Resources

• Presentations
• Practical working sessions
• Course evaluation

Program:

• The regulatory context surrounding the revision of the ISO 13485 standard;
• The areas of increased emphasis on ISO 13485:2016 (Risk management, software validation, etc.);
• The additions, key requirements, and evolutions of the ISO 13485 standard:
• A Clause by Clause review of the changes in the 2016 version of ISO 13485:
• Clause 3: Definitions
• Clause 4: General requirements introduced by ISO 13485:2016
• Clause 5: Management Responsibility
• Clause 6: Resource Management
• Clause 7: Product Realization
• Clause 8: Measurement, Analysis, and Improvement
• Practical working sessions
• Group workshop
• Course Evaluation
• Summary and Discussion with the trainer