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
Speaker: Jordan Elder, Director, Regulatory Affairs, Regulatory Compliance Associates (RCA)
ISO 13485 & Audit Readiness
Speaker: Jordan Elder, Director, Regulatory Affairs, Regulatory Compliance Associates (RCA)
Risk Management Workshop (ISO 14971)
Speaker: Jordan Elder, Director, Regulatory Affairs, Regulatory Compliance Associates (RCA)
FDA guidance on categories of sterilization processes and changing between sterilization modalities
Speaker: Martell Winters RM/SM (NRCM), CISS-RAD, Nelson Labs
Updates to 10993-1 on risk assessments for biocompatibility
Speaker: Robert Mueller, Nelson Labs
Roundtable Discussion
Speakers: all presenters
Day 2: The Testing & Validation Intensive
Biocompatibility Deep Dive (ISO 10993)
Speaker: Robert Mueller, Nelson Labs
Packaging Validation (ISO 11607)
Speaker: Martell Winters RM/SM (NRCM), CISS-RAD, Nelson Labs
Microbiology & Sterilization Science
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
Speakers: all presenters
Day 3: Infrastructure, Software & Global Access
Software Validation & Cybersecurity
Speaker: Jordan Elder, Director, Regulatory Affairs, Regulatory Compliance Associates (RCA)
Global Market Entry (US/EU/UK/JP)
Speaker: Jordan Elder, Director, Regulatory Affairs, Regulatory Compliance Associates (RCA)
Facility Briefing & Sterigenics Site Tour
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.
