2018 Educational Resources

The experts at Nelson Labs deliver added value by producing free educational resources with the aim of educating our customers with the most current industry insights. This information is provided by our experts who actively participate on standards committees and work within the industry and regulatory groups that shape the future of MedTech and pharma standards (AAMI/ISO/ASTM/PDA).

We rounded up the whitepapers, published articles, webinars, and tech theater videos that were created in 2018 and listed them here for your review. However, if you would like to join us for a more in-depth training, we recommend you attend one of the Nelson Labs multi-day seminars we offer in the Unites States and Europe or contact our expert advisory services team  at [email protected] for more information.

WHITEPAPERS
Our whitepapers allow you to dig deeper into topics and understand the science behind our services, as well as ways we can help solve your business challenges.

1. EO Residue Levels in Medical Devices: Best Practices for Demonstrating Compliance with ISO 10993-7
   Authors: Thor Rollins, Gregory Grams, Mike Padilla, Peter Strain, and Erik Haghedooren

PUBLISHED ARTICLES
Our experts are featured in industry-leading publications and provide deep insights for the MedTech industry.

1. Validation of a sterilization dose for products manufactured using a 3D printer

• ScienceDirect
• Authors: Wendy Wangsgard, Martell Winters

2. What Medical Device Manufacturers Need to Know about FDA’s Predictive Toxicology Roadmap

• MDDIonline
• Authors: Trevor Fish and Sarah Campbell

3. ANSI/AAMI PB70: Closing the Gap

• MDDIonline
• Author: Sarah Smit

4. Package Engineering for Sterilization

• Medical Design Briefs
• Author: Andrew Manrique

5. A Brief Introduction to Medical Device Biocompatibility

• MDDIonline
• Author: Matt Jorgensen

6. Passing the test: Why patient safety is paramount

• Medical Plastics News
• Authors: Matthew Jorgensen, Thor Rollins, Piet Christiaens

7. How Clean is Clean Enough: Here are some takeaways from ISO 19227 for orthopedic implants

• MDDI Online
• Authors: Audrey Turley, Matt Jorgensen, & Erin Bakes

8. Package Engineering considerations for Medical Device Sterilization

• Packaging Digest
• Authors: Wendy Mach & Andrew Manrique

9. Five Aspects of the ISO 11737-1:2018 Updates You Need to Know

• MPO
• Martell Winters & Wendy Wangsgard

10. Reusable Medical Devices: BI Selection, Overkill Validation Approaches, and First-Time Validation Pass Rates in Common Healthcare Steam Sterilization Cycles

• Medical Design Briefs
• Robert Mueller, Blake Northrup, & Jason Pope

11. Are You Really Ready For MDR?

• MD+DI
• Featuring: Audrey Turley

12. Understanding Worst-case Conditions in ISO 18562 Testing

• Medical Design & Outsourcing
• Matt Jorgensen, Erin Bakes, & Robert Mueller

13. Resourceful Thinking

• Medical Plastics News
• Author: Wendy Wangsgard

14. Consider the Most Probable Number Method for Bioburden Testing

• MDDI
• Authors: Sean Shepherd & Martell Winters

15. Understanding the importance of TIR17 for medical device manufacturers

• Medical Plastics News
• Wendy Wangsgard, PhD

WEBINARS
On-demand opportunities to learn from our experts on industry topics.

1. Satisfying ISO 18562 and FDA Biocompatibility Regulatory Requirements for Breathing Gas Pathways in Health Care Application
   Audrey Turley
2. New Guidance on Product Family Adoption for Radiation Sterilization: TIR 35:2016
   Wendy Wangsgard & Martell Winters
3. Ethylene Oxide Sterilization, Revision of Annex E, Single Batch Release
   Paul Littley & David Gilbert
4. Changing Expectations with Endoscope Reprocessing
   Jason Pope & Alpa Patel
5. What is Changing in the Global Regulatory Landscape
   Thor Rollins
6. Chemical Characterization and Toxicological Risk Assessment for Medical Device Biocompatibility
   Matthew Jorgensen & Annelies Vertommen
7. How to Address Regulatory Change in Your Current Biocompatibility Program
   Audrey Turley
8. Packaging Design Validation Testing
   Pal Khangaldy

TECH THEATER VIDEOS
Videos from our experts sharing the latest industry information.

1. Chemical Characterization: How to Prepare for the Future in This Time of Transition
   Matthew Jorgensen
2. Extractable and Leachable Chemistry Testing: How to Prepare for the Future
   Matthew Jorgensen
3. The Future of Biocompatibility: Industry Trends and Hurdles
   Matthew Jorgensen
4. MD&M East Tech Theater: The Future of Biocompatibility Industry Trends and Hurdles
   Matthew Jorgensen
5. The Journey of Revealing Unknowns and Impurities by Material
   Lise Vanderkelen

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