Invitation to our Seminar ‘Validation of Sterile Medical Devices Frankfurt 2026’
Register now for a seat!
We’re pleased to invite you to our three-day seminar ‘Validation of Sterile Medical Devices Frankfurt 2026’, 24-26 February, in Frankfurt, Germany, preceded by an optional guided lab and facility tour at our Nelson Labs & Sterigenics Wiesbaden site on 23 February.
This seminar will provide valuable insights into key topics that are essential for industry professionals:
- The seamless integration between Sterigenics and Nelson Labs from Sterility processes up to sterility validation testing
- Sterilization modalities for medical devices and applicable considerations such as dose establishment and dose audits
- Considerations for packaging, including practical sessions on mock devices
- Insightful reflections on the MDR
- Considerations for the healthcare reprocessing of reusable medical devices
- Cleaning validations after manufacturing for single use devices
- Biological safety assessments and associated testing, including recent updates of ISO 10993-1
Guided lab & facility tour in Wiesbaden – 23 February, 2026 (at 45 min from International airport in Frankfurt-by train)
This tour is optional and for free and will take place in the Wiesbaden Nelson Labs & Sterigenics facility.
When: 3pm at the Sterigenics facility
How: In separate groups of 6 people. We will pick you up in front of the industrial park of InfraServ
Duration: +/-2 hours
Where: Kasteler Straße 45, TOR NORD of the industrial park of InfraServ
Public transport: There is direct train from the Frankfurt airport to the Wiesbaden Biebrich railway station (45 min), located directly in front of the industrial park.
By car: 30 min from Frankfurt airport to Wiesbaden
Seminar participants will enjoy classes taught by industry-leading advisors from Nelson Labs and Sterigenics.
Seminar attendance can be used for RAC (RAPS), ASQ and AAMI credit hours.
View the agenda here: Validation of Sterile Medical Devices Frankfurt 2026
COURSE HIGHLIGHTS INCLUDE THE FOLLOWING:
Introduction to Microbiology & Sterilization
This course offers attendees an opportunity to brush up on the basics of sterilization, microbiology, and important medical device industry terms.
Speaker: Peter Cornelis Ir.
From regulation to readiness: MDR changes that matter
The session will provide an update from the regulatory field surrounding medical devices in the EU. The latest news concerning applicable legislation and guidance will be presented, and the impact on time to market, as well as on devices on the market, will be discussed. Best practice advice will be shared, with a mission to decrease the likelihood for costly delays and missed goals. The interactive session will end with time for Q&A.
Speaker: Jennie Sandström, Senior Director, Quality and Regulatory Affairs, CRO & Consulting Services, Veranex
Ethylene Oxide Sterilization Validation
This comprehensive training will teach you how to develop and validate an Ethylene Oxide (EO) sterilization process that achieves the required sterility assurance level (SAL).
You will begin with the core principles of EO sterilization, building a strong technical foundation. Then, you will move step by step through the practical aspects of process validation, including Product & Process definition, Process validation and Process Requalification.
By the end, you will have a clear understanding of how EO cycles are validated, of what is required to meet regulatory expectations, and how to ensure your organization delivers safe, sterile products and stays audit-ready
Speaker: Jean François Zeevaert, Sterigenics
Biocompatibility / ISO 10993
With 24 possible categories, the biocompatibility testing experience can be intimidating. This course will help you understand the testing requirements of ISO 10993 and how to choose the correct test methods for your product.
In addition to a biocompatibility overview, this course will highlight key terms and definitions, a general overview of each of the test options, and applicable case studies. Lastly, this course will teach you how to categorize your product according to the ISO 10993 table.
Speakers: Natascha Arnouts, Elisabet Jamez
Chemical Characterization
This course will help you understand the analytical chemistry techniques that can be used to characterize device materials and evaluate extractable/leachable compounds.
This testing is being used in the industry to evaluate changes made to device materials and processing as well as supplement biocompatibility testing. These test methods are becoming a popular alternative for animal testing.
Speaker: Koen Van der Plas, PhD
Packaging Fundamentals – Design and Validation Considerations
Focused on the requirements outlined in ISO 11607, this course will help you understand packaging validations and how to successfully navigate the package testing arena.
This topic is designed to provide a general background of the packaging standards and what options are available for completing a validation. Several of the different types of tests are discussed along with the purposes and data they provide.
Speaker: Logan Luke B.S.
Radiation Sterilization Validation
This class teaches students how to perform radiation validations, review bioburden data, deal with sterility test failures, and understand the various radiation options (gamma, electron beam, and X-ray).
Training begins with the fundamentals of Radiation including the background of gamma and radiation, and key terms and definitions. This training then highlights how and why bioburden testing is completed. The different types of methods for doing radiation sterilization including VD Max, Method 1 and Method 2 are discussed in detail. Lastly, the topic covers several of the standards along with case studies and examples.
Speaker: Bart Croonenborghs, PhD
Cleaning, Disinfection, and Sterilization Validations of Reusable Medical Devices
This training will teach attendees the information and processes involved in the validation of health care device reprocessing instructions. Highlights include discussion of the guidance documents, standards, industry trends, and the acceptance criteria including contamination, cleaning, extraction, and residual testing for cleaning validations. Course will also cover how to plan for and perform each of these validations as well as simulated use and end of life testing. The disinfection training will include disinfection classifications and acceptance criteria as well as neutralization, inoculation, disinfection methods and solutions, extraction, and testing methods. The sterilization validations training will include inoculation, parameters for sterilization, dry time testing, and temperature profiling.
Speakers: Katleen Peymen, PhD & Lieze Vanderheyden
Cleaning Validations for Newly Manufactured Devices and Single-Use Implants
The importance of manufacturing clean devices will be discussed during this course, and how cleanliness should be evaluated in addition to the sterility and biocompatibility of a device.
Topics of discussion will include test methods to evaluate manufacturing and cleaning residues, along with information regarding sampling, routine monitoring, and determining acceptance criteria.
Speaker: Elisabet Jamez
CHECK BACK FOR DETAILED COURSE INFORMATION AND THE AGENDA COMING SOON.
Registration Details:
Registration on/before December 22, 2025 is $900 USD.
Registration after December 22, 2025 is $1050 USD.
Deadline for all registrations is 9th February, 2026. (please note the deadline for hotel reservations, which is 8th January 2026)
Groups of three or more may contact
Isabelle Liesenborghs at [email protected] or +32 472 23 06 07 for information about discounted pricing.
Hotel Accommodations:
Guests planning to stay on location may coordinate their hotel reservation with the Hilton Frankfurt Airport. Once you have registered, you will receive an email with a link for a discount code for hotel reservations at the Hilton (available until 8th January 2026).
Please note that the seminar registration fee does not include hotel accommodations.
Other Details:
Lunch and refreshments will be served daily and are included in the seminar package.
*As with all RAPS, ASQ, and AAMI credit hours, it is the responsibility of the individual to keep record of course participation and materials.
