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    Medical devices

    Internal audits based on ISO 13485 for medtech organizations

    In this two-day course, in cooperation with Intertek Academy, you will get a basic understanding of the requirements that will help you succeed in carrying out internal audits in a way that will really benefit the development of your organization.
    For most companies, continually improving the organization is a matter of survival. Internal auditing is a powerful tool for studying the operations in a structured way, with the intention of developing them.

    As an internal auditor, having a knowledge of auditing techniques and methodologies is central in order to turn auditing results into improvements to the organization. Having a good understanding of the requirements in the current standard is also important. In this course, you will get a basic understanding that will help you succeed in carrying out internal audits in a way that will really benefit the development of your organization.

    The theoretical part of the course focuses on auditing techniques and methodology and provides the tools you need to carry out an audit in a professional manner. The practical part of the course includes audit preparation and deviation identification. All exercises and examples are related to ISO 13485.

    Topics

    • Techniques and approaches
    • Different types of audits
    • The psychology of auditing
    • Internal audit planning
    • Audit programs and audit plans
    • Designing a deviation report
    • Designing an audit report
    • Deviation follow-ups

    Trainers

    Ladan Amiri
    Ladan Amiri
    Senior Quality and Regulatory Consultant
    Ladan holds an M.Sc. in Applied Physics and Electrical Engineering/Biomedical Engineering and brings over 30 years of experience in the medical device industry, spanning start-ups, large organizations, and global companies. She specializes in MDR/IVDR, ISO 13485, QSR/QMSR, MDSAP, internal and supplier auditing, and working with Notified Body auditors, with deep expertise across the full product life cycle. She excels at translating complex standards and regulations into practical processes, procedures, and SOPs. A passionate training leader in ISO 13485 and internal auditing, Ladan helps teams build audit readiness, regulatory compliance, and strong quality cultures, including preparation for Notified Body (NB) audits, while driving continuous improvement and operational efficiency.

    Target group

    This course is intended as an introduction for professionals who are involved in carrying out internal audits according to ISO 13485 or who are responsible for audits within an organization. We recommend that participants in this course are familiar with quality management systems for medtech organizations.

    Objectives

    After the course, participants will be able to carry out an internal audit of their organization in a professional manner that will contribute to the improvement of operations.

    Additional information

    The course costs 13 900 SEK (excluding local VAT). The course material is in English, and the course is held in English.

    Related courses

    Quality management system according to EN ISO 13485:2016 – in practice
    The two-day course, in cooperation with Intertek Academy, provides a basic understanding of the requirements and how to design, deploy and maintain a working quality management system.