Introduction to the Validation of Sterile Medical Devices: Sterilization, Packaging, Biocompatibility, Toxicology, and Reprocessing

For over a decade, Nelson Laboratories has been hosting educational seminars called The Science of Sterilization Validation. The aim of these three-day seminars has been to provide MedTech professionals the opportunity to establish or refresh their fundamental testing knowledge and, thereby, achieve more efficient, accurate, and effective testing outcomes.

As the needs of our customers have evolved, we have continuously updated our seminars to meet those changing needs.  To better align with the new, more comprehensive agenda, Nelson Labs is re-naming the seminar to: Introduction to the Validation of Sterile Medical Devices: Sterilization, Packaging, Biocompatibility, Toxicology, and Reprocessing. The program will continue to be RAPS and ASQ approved for 12 RAC and 1.2 ASQ credit hours and may also qualify for AAMI credit hours. Courses are taught by Nelson Labs’  and SteriPro’s scientific experts. Highlights include, but are not limited to:

  • Introduction to Microbiology & Sterilization:
    The introduction offers attendees an opportunity to brush up on the basics of sterilization, microbiology, and important industry terms.
  • Ethylene Oxide Sterilization Validation:
    Learn how to develop, optimize, and validate a successful ethylene oxide sterilization process that delivers the necessary sterility assurance level and ensures repeatability.
  • Biocompatibility / ISO 10993:
    With 24 possible categories, the biocompatibility testing experience can be intimidating. We will help you understand the testing requirements of ISO 10993 and how to choose the correct test methods for your product.
  • Chemical Characterization / E&L Assessments:
    This topic will help you understand the analytical chemistry strategies that can be used to characterize device materials and evaluate extractable/leachable compounds.
  • Packaging Overview / ISO 11607:
    Focused on the requirements outlined in ISO 11607, this subject will help you understand packaging validations and how to successfully navigate the package testing arena.
  • Radiation Sterilization Validation:
    Attendees will learn 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).
  • Cleaning, Disinfection, and Sterilization Validations of Reusable Medical Devices:
    Our experts will teach attendees the information and processes involved in the validation of healthcare device reprocessing instructions. Highlights include discussion of the guidance documents, standards, industry trends, and the acceptance criteria.
  • Cleaning Validations for Newly Manufactured Devices and Single Use Implants:
    The importance of manufacturing clean devices will be discussed, and how cleanliness should be evaluated in addition to the sterility and biocompatibility of a device.

The full seminar is appropriate for professionals who are new in their role as well as for MedTech veterans. Lectures are presented by industry-leading experts and include case studies, hands-on activities, Q&A, and one-on-one time with the speakers. 100% of post-seminar survey respondents have expressed that they would recommend the seminar to a colleague or friend.

Visit the Seminar page on the Nelson Labs’ website to learn more about the next seminar near you.

For more information regarding our seminars, contact the Nelson Labs’ marketing department:

Considerations for Sterilization and Biocompatibility of 3D-Printed Orthopedic Devices

Thor Rollins, Martell Winters, and Matthew Jorgensen, PhD collaborated on a whitepaper that is available for download: Considerations for Sterilization and Biocompatibility of 3D-Printed Orthopedic Devices

This whitepaper is an in-depth look at the various biocompatibility and sterilization considerations surrounding 3D-printed orthopedic devices. 3D-printed orthopedic medical devices are gaining attention and popularity due to their potential for enhanced biocompatibility, customizability, and cost-effectiveness. As of late 2015, FDA had cleared more than 85 total 3D-printed medical devices, with more regulatory clearances on the horizon.

The whitepaper is available for download on the Qmed website or click HERE.

Nelson Laboratories Exhibiting at MEDevice San Diego 2014

Visit Nelson Laboratories booth #23 at MEDevice San Diego 2014

Visit Nelson Laboratories booth #23 at MEDevice San Diego 2014

Join Nelson Laboratories, Inc. and other medtech industry leaders exhibiting at MEDevice San Diego September 10 – 11, 2014 at the San Diego Marriott Marquis & Marina Hotel.

Nelson Laboratories will have consultants available for MEDevice Conference and Showcase participants at booth #23 to answer technical questions including but not limited to: designing medical devices for biocompatibility, sterilization, and cleaning. Nelson Laboratories is also proud to announce that Emily Mitzel, Laboratory Manager, will be presenting Thursday September 11, 2014 from 2:30 – 3:15 pm.

MEDevice COURSE SPOTLIGHT: Mark your calendar for Emily Mitzel’s conference presentation, Planning for Product Validations: Designing for Biocompatibility, Sterilization, and Cleaning Thursday September 11, 2014 from 2:30 – 3:15 pm in the Marina Ballroom. Part of Conference Track A, Emily’s presentation will highlight:

  • Material selection and processing factors that affect biocompatibility
  • Designing for sterilization: What you should know from the start
  • Human factors and designing for cleaning and reprocessing at the clinical site

Nelson Laboratories in conjunction with MEDevice San Diego, is proud to extend a 20% conference discount and complimentary admission to the 2014 MEDevice Showcase and Reception. Contact Mike Pizzi ( to acquire the necessary discount codes.

About MEDevice San Diego: Since 2011, MEDevice San Diego has attracted leading industry experts to the thriving San Diego medtech community for this two-day event. With over 30 conference sessions, 50 presenters, an exhibitor-filled Tech Showcase, and exclusive networking opportunities, this is an event you won’t want to miss.