Sterilization of Medical Devices

Take Control of Sterilization; become the expert your Team needs

April 20 (online)  PLUS  April 27, 28 and 29 (onsite, DGI Byen, Copenhagen)

– Are you responsible for auditing, assessing, or establishing sterilization processes for medical devices?

In an industry where compliance, safety, and effectiveness are non-negotiable, your expertise in sterilization can make all the difference. Our renowned 4-day training course provides the in-depth, up-to-date knowledge you need to excel at every stage — from process selection and validation to ongoing effectiveness and audits. After the training you can undergo an exam to verify your learning (read more about the course content and the exam in the “Course outline”, see link below).

Why Choose This Course?

• Proven Track Record: Developed in the late 1990s for university-level education and available to the public for over 20 years, this course has successfully trained and certified more than 100 professionals.
• Comprehensive Curriculum: Covering every major sterilization method—including irradiation, ethylene oxide, moist heat, and dry heat—you’ll master the requirements and skills to define and assess each process.
• Regulatory and Standards Focus: Gain deep understanding of key international standards (ISO 14937:2009, ISO 17665, EN 556-1, and more) and learn to apply them directly to your work.
• Expert-Led Training: Learn from seasoned instructors with decades of experience in medical device sterilization and quality management.
• Validation and Auditing Skills: Become adept at both setting up and auditing sterilization processes for compliance with ISO standards and Quality Management Systems.

Learning objectives

By the end of this course, you will:

• Identify, select, and implement the most suitable sterilization methods for a variety of medical devices and manufacturing environments.
• Understand and apply the principles of ISO sterilization standards, guidance documents, and quality management requirements.
• Grasp essential microbiology for achieving and assuring sterility, including bioburden concepts and sterility assurance testing.
• Audit and validate sterilization methods with confidence, ensuring your processes meet regulatory expectations and pass inspections

Course outline

• General Requirements for Sterilization of Medical Devices (ISO 14937:2009)
• Microbiological methods- Part 1. Determination of population of microorganisms (ISO 11737-1:2018)
• Sterility testing: the Pharmacopoeia ‘Test for sterility’ versus’ Test of sterility’
• Microbial inactivation kinetics – Requirements for terminally sterilized device to be designated “STERILE” (EN 556-1)
• Biological indicators (ISO 11138-1:2017)
• Clean rooms (ISO 14644, Part 1–5)
• Tests of sterility performed in the definition, validation and maintenance of a sterilization process. (EN ISO 11737-2:2019)
• Packaging for terminally sterilized medical devices – Requirements on materials, sterile barrier system and packaging systems (ISO 11607-1:2019)
• Radiation sterilization (ISO 11137-1, -2, -3)
• Ethylene oxide – Validation and routine control of the sterilization process (ISO 11135:2014)
• Moist heat – Validation and routine control of the sterilization process  (EN ISO 17665:2024)
• Dry heat — Validation and routine control of the sterilization process (ISO 20857:2013)

Download full Course Outline (PDF) >

Important information:

1. Before the course:
   The course literature is distributed as e-book 4 weeks before the training.
   To get the most out of the training it is highly recommended that you read this book and get well familiarized with the content.
2. During the course:
   It is important to note that the 4 course days are split up, and consists of a 1 day (instructor-led) online training and 3 days onsite.
3. After the course:
   You can choose to undergo an examination to verify your knowledge. The exam consists of eight questions that shall be answered with free text (there are no alternatives to choose from). It is an open exam, so you can make use of the e-book, the training material and any other information while preparing the answers, but please note that it is an individual test, meaning that no co-operation with other attendees may occur when preparing the answers.

Who should attend

• Quality assurance and regulatory affairs professionals
• Auditors and assessors of medical device manufacturing
• Engineers and technicians setting up or validating sterilization processes
• Anyone seeking to master international sterilization standards and state-of-the-art practices

Need of prior knowledge/experiences

• Academic education in engineering or life sciences.
• Basic knowledge in medical device regulations and the role of standards
• 6-12 months experience of working in the regulated industry (medical device or pharmaceutical industry), alternatively from working at an authority or Notified Body.

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