Overview

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Course Overview

  • Duration: 8 hours
  • Cost: $950 USD

In this training, participants will deepen their understanding of the requirements for the sterilization, which serve as the basis for the manufacture of sterile medical devices.

This overview includes important aspects, such as the validation and documentation of sterilization processes in the medical device industry and the participant will gain indispensable expert knowledge from our experienced professionals, to ensure a valid and compliant sterilization process can be implemented.

In the training, we will delve deeper into specific aspects of various sterilization processes and focus on relevant standards harmonized under Regulations (EU) 2017/745 (MDR) and 2017/746 (IVDR) including: EN ISO 17665 series, EN ISO 11135, EN ISO 11137 series, and EN ISO 14937.

By completing this course, participants will be well-equipped with an understanding of sterilization requirements and application within the manufacturing of medical devices and in-vitro diagnostics, as well as receive a Certificate of Completion.

Learning Objectives
After taking this course, participants will obtain a better understanding of the following areas:

  1. Introduction to EU Regulatory Framework
    • Overview of the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR)
    • Key regulatory bodies and their roles
  2. Sterilization Methods and Requirements including:
    • Steam sterilization (EN ISO 17665 series)
    • Ethylene oxide (EtO) sterilization (EN ISO 11135)
    • Radiation sterilization (EN ISO 11137 series)
    • EN ISO 14971: Application of risk management to medical devices
  3. Process Validation and Control
    • Principles of sterilization validation (EN ISO 14937) including:
      • Process control and monitoring
      • troubleshooting and problem-solving
    • Cleanrooms (EN ISO 14644)
  4. Documentation and Quality Management
    • Technical documentation requirements (as per Annex II MDR/IVDR)
    • Quality management system (QMS) requirements
    • Conformity assessment procedures
  5. Case Studies and Practical Applications
    • Real-world scenarios and situational analyses
    • Interactive exercises and group discussions

Ideal Target Audience
Medical device manufacturers, particularly persons responsible for the validation of sterilization, preparation of technical documentation or employees from the development and quality assurance departments would find the most value from this course.

Instructor Information
Our trainers have a deep understanding of certification processes and have worked with international manufacturers and certification bodies.

Naomi Knopjes has a Master’s degree in Biochemistry and international experience in several different roles at various IVD manufacturers. There, she gained a deep technical knowledge about the practical application of sterilization processes. Naomi is a Certification Decision Maker at CSA Group and works on the establishment of a QM-system regarding IVDR. She is an auditor for medical devices.

Sigrid Uhlemann is a Healthcare Regulatory Program Manager at CSA Group. She has over 20 years of experience in medical device certification and possesses extensive knowledge of applicable regulatory requirements, including technical documentation, and is well-versed in the latest regulatory developments. Sigrid is an auditor for ISO 13485, MDSAP, and MDR.

She has conducted several training sessions for auditors and reviewers and developed practical solutions for regulatory requirements. Her training combines theoretical knowledge with practical examples, focusing on making complex regulatory requirements understandable and actionable.

Benefits of Our Training

  • Practical Implementation: Engage in practical exercises and gain actionable insights and tools to fulfill the requirements of applicable standards.
  • Enhanced Knowledge: Acquire essential knowledge to enhance their expertise in sterilization methods, validation processes, and their documentation.
  • Certificate: Participants will receive a certificate upon successful completion of the course, confirming their theoretical knowledge of the applicable standards and their practical application.
  • Expert Instructors: Our experienced trainers bring real-world knowledge and industry-leading insights to the classroom. They have a deep understanding of medical device certification.
  • Gain Confidence: Our training will equip your team with greater confidence in navigating applicable standards and helping you to fulfill the requirements of the respective regulations.
  • Private or Public: We offer both public and private courses. For organizations with 10 or more participants, we can administer private training courses — allowing your team to ask questions and receive guidance tailored to your business. For organizations with less than 10 participants, we recommend our public courses. Our public courses have been designed by our medical device experts to help your team understand a range of complex sterilization related topics.

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