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ISO 13485 Medical Devices Barcelona

November 2 - November 4

ISO 13485 Medical Devices

This 3-day course covers not only the ISO standard itself, but also the ancillary processes and guidelines needed to effectively apply the standard to the development, manufacturing, implementation, and commissioning of medical devices. The ISO standard simply provides a checklist of tasks and procedures needed to effectively create, deploy and use the devices, but lacks real-world examples and applications, which are crucial in effectively understanding the intent of the standard. To that end, we assist participants to clearly interpret and implement the standard through actual case studies.

Course Overview

We design our ISO 9000 workshops to fit our clients’ needs and objectives. Therefore, our workshops include hands-on exercises and real-world case studies similar to what the client encounters on a regular basis. Additionally, we provide follow-up consulting for up to 60 days after the participants have finished the workshop to address any questions or issues. The course work includes:

  • Introduction to the ISO 13485 Starter Guide
  • The Quality Management System
  • The Lifecycle of the Medical Device
  • Specific Definitions and Concepts of this ISO
  • Regulatory Requirements
  • Resource Management
  • Product Realization and Inspection
  • Improvements, Corrective Action and Preventive
  • Current Good Manufacturing Practice (cGMP)
  • The importance of defining Non-Conformity; Major versus Minor
  • Review course and evaluate participants’ class assignments


None, but a basic understanding of the ISO standards is helpful

Target Audience

    • Designers, manufacturers, reviewers, and operators of medical devices
    • Quality managers and staff
    • Quality auditors
    • Quality auditees

Learning Outcomes

After successful completion of this workshop, the participant shall be able to:

  • Gain a comprehensive understanding of this standard
  • Understand and practice implementing the standard
  • Learn how to develop a Quality Management Plan for this ISO
  • Develop quality objectives and metrics
  • Create unique quality checklists
  • Identify and control quality risks
  • Create and implement a staff training plan
  • Work effectively with clients, suppliers, operators, technicians and other personnel working with medical devices

Professional Development Units/Hours (PDUs) Awarded

    • 24 PDUs (1 hour = 1 PDU)


November 2
November 4
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+34 645 37 94 43
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