Learn how to achieve more successful testing outcomes by attending our MedTech Lifecycle Seminar: Design, Validation & Regulatory Compliance. The aim of this three-day seminar is to provide MedTech professionals the opportunity to establish or refresh their fundamental testing knowledge and, thereby, achieve more efficient, accurate, and effective testing outcomes.
Seminar participants will enjoy classes taught by industry-leading advisors from Nelson Labs and Sterigenics.
This seminar is RAPS and ASQ approved and is eligible for 12 RAC and 1.2 ASQ credit hours. Courses may also qualify for AAMI credit hours.*
COURSE HIGHLIGHTS INCLUDE THE FOLLOWING:
Download the agenda here: Seminar Agenda
Day 1: Regulatory Strategy & Quality Systems
QMSR Transition
This session provides a strategic framework for transitioning from FDA 21 CFR Part 820 to the new Quality Management System Regulation (QMSR). Attendees will gain a clear understanding of regulatory expectations, implementation timelines, and practical steps to align existing quality systems with harmonized global requirements, minimizing disruption while ensuring compliance.
Speaker: Jordan Elder, Director, Regulatory Affairs, Regulatory Compliance Associates (RCA)
ISO 13485 & Audit Readiness
Through real-world case studies, this session explores how to maintain a compliant and inspection-ready quality management system. Participants will learn best practices for preparing for unannounced audits, managing inspection findings, and sustaining continuous audit readiness across global regulatory environments.
Speaker: Jordan Elder, Director, Regulatory Affairs, Regulatory Compliance Associates (RCA)
Risk Management Workshop (ISO 14971)
This interactive workshop focuses on applying ISO 14971 principles to modern regulatory expectations. Participants will work through practical examples to align risk management files with EU MDR and FDA requirements, strengthening risk-based decision-making throughout the product lifecycle.
Speaker: Jordan Elder, Director, Regulatory Affairs, Regulatory Compliance Associates (RCA)
FDA guidance on categories of sterilization processes and changing between sterilization modalities
This session reviews updated FDA guidance on sterilization process categories and regulatory considerations when changing modalities. It also highlights AAMI advancements in novel sterilization methods, helping participants understand evolving expectations and innovation pathways.
Speaker: Martell Winters RM/SM (NRCM), CISS-RAD, Nelson Labs
Updates to 10993-1 on risk assessments for biocompatibility
An overview of the latest revisions to ISO 10993-1, emphasizing risk-based biocompatibility assessment strategies. This talk addresses how to optimize testing plans, reduce unnecessary testing, and align with current global regulatory expectations.
Speaker: Robert Mueller, Nelson Labs
Single Use Cleaning Validations (ISO 19227)
Speaker: Robert Mueller, Nelson Labs
Roundtable Discussion
A collaborative forum where participants engage directly with subject matter experts to discuss challenges, share experiences, and explore solutions across regulatory, quality, and validation topics.
Speakers: all presenters
Day 2: The Testing & Validation Intensive
Biocompatibility Deep Dive (ISO 10993)
This technical deep dive covers material characterization and biological evaluation strategies for Class II medical devices. Attendees will learn how to design effective biocompatibility plans, interpret test data, and ensure defensible regulatory submissions.
Speaker: Robert Mueller, Nelson Labs
Packaging Validation (ISO 11607)
A hands-on workshop focused on designing and executing packaging validation studies. Topics include shelf-life testing, distribution simulation, and the application of design of experiments (DOE) to ensure packaging integrity through the product lifecycle.
Speaker: Martell Winters RM/SM (NRCM), CISS-RAD, Nelson Labs
Microbiology & Sterilization Science
This session explores core microbiological principles and sterilization validation strategies, including ethylene oxide (EO) and radiation methods. Participants will gain insight into bioburden control, environmental monitoring, and establishing effective sterilization processes.
Speakers:
Martell Winters RM/SM (NRCM), CISS-RAD, Nelson Labs
Yesi Frago, General Manager, Sterigenics
Product Lifecycle Case study incorporating all aspects of testing and regulatory
A comprehensive case study demonstrating how regulatory, biocompatibility, packaging, and sterilization considerations integrate across the full product lifecycle. This session reinforces cross-functional decision-making and real-world application.
Speakers: all presenters
Day 3: Infrastructure, Software & Global Access
Software Validation & Cybersecurity
This session addresses validation challenges for connected medical devices and Software as a Medical Device (SaMD). Topics include cybersecurity risk management, software lifecycle validation, and regulatory expectations for digital health technologies.
Speaker: Jordan Elder, Director, Regulatory Affairs, Regulatory Compliance Associates (RCA)
Global Market Entry (US/EU/UK/JP)
A technical overview of the regulatory pathways for entering key global markets. Participants will learn how to navigate EU MDR, UKCA requirements, and other international frameworks, with a focus on Class II devices.
Speaker: Jordan Elder, Director, Regulatory Affairs, Regulatory Compliance Associates (RCA)
Final Wrap-Up & Q&A
A closing session summarizing key takeaways from the program and providing an opportunity for attendees to ask final questions and clarify complex topics with all presenters.
Speakers: all presenters
Facility Briefing: EO Sterilization
A pre-tour technical briefing covering ethylene oxide sterilization processes, safety considerations, and logistical aspects of terminal sterilization in large-scale operations.
Speaker: Yesi Frago, General Manager, Sterigenics
Sterigenics Site Tour
This tour of Sterigenics’ Costa Rica facility will highlight ethylene oxide sterilization. Participants will tour the warehouse and processing areas and learn first-hand from their engineers, Quality Assurance, and EHS professionals. Tour space is limited and subject to approval.
Please note: Closed-toe shoes are required for the tour. Additionally, a signed visitor agreement regarding confidentiality and nondisclosure will be required for participants.
Registration Details:
Choose between attending all three days or any one or two!
Select which days when you register:
1 day – $195
2 days – $325
3 days – $400
Deadline for all registrations is October 2, 2026.
Groups of three or more may contact Mike Pizzi at [email protected] or +1 (801) 290-7524 for information about discounted pricing.
Hotel Accommodations:
Guests planning to stay on location may coordinate their hotel reservation with Hilton San Jose La Sabana.
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.
Presenting Experts:
Martell Winters
RM/SM (NRCM), CISS-RAD
Sr. Manager, Scientific Business Development
Martell Winters is a specialist microbiologist (NRCM) and a radiation specialist (AAMI). He has been at Nelson Labs for 24 years and spent his earlier years working in the Radiation Sterilization group, responsible for bioburden testing and radiation validation studies. His specialties include microbiological process validation and radiation sterilization of medical devices, allograft tissue, and pharmaceutical products.
Jordan Elder
RAC
Regulatory Affairs Expert
Jordan has 15 years of experience navigating regulatory pathways and identifying optimal regulatory strategies for pharmaceutical and medical device companies. As Director of Regulatory Affairs for Regulatory Compliance Associates (RCA) he is responsible for providing clients with general direction, tactical objectives, and functional plans for their regulatory needs. Jordan is a meticulous regulatory professional with...
Robert Mueller
Sr. Expert Consultant, Toxicologist, Nelson Labs
Robert Mueller has 8 years of experience working in the medical device industry. He has developed a unique perspective on testing from working for both a contract research organization and a medical device manufacturer. During his time with the medical device manufacturer, he planned and managed the execution of biological testing, chemical characterization, and wrote...
