MedCon 2024, co-sponsored by the FDA

2024 MedCon Workshop

On Tuesday, April 23, there will be a full-day, pre-conference workshop focused on machine learning in artificial intelligence (AIML) available for an additional fee. Additional details about the MedCon 2024 workshop will be announced soon. In the meantime, here are details from last year’s event that you can review to get an idea of how we will tackle a vital issue.

This in-depth, pre-conference workshop took place on April 24, 2023.

Risk Management: Practical Applications of Risk Management Throughout the Device Life Cycle

Jump-start your deeper understanding of RMS regulatory authority expectations!

This workshop is meant for beginner to intermediate practitioners who want to go beyond the basic understanding of risk management system (RMS) requirements. The workshop will give a brief overview of the history of regulatory authority expectations related to risk management activities and delve into these practical topics with breakout group activities and discussions:

• Value of well-established risk assessment criteria
• Traceability tables from design specifications to IFUs to market applications
• Human Factors/Usability testing over the lifetime of your medical product
• Understanding the global regulatory authority sensitivity regarding “use errors”
• Pulling premarket risk data through to post-market data
• Correlating RMS data to post-market IMDRF Adverse Event Codes
• Product Risk Assessments for possible escalations to Field Safety Corrective Actions/Recall decisions.

APRIL 24, 2023 — MedCon Workshop Agenda

7:00 A.M. – 8:00 A.M.

Breakfast

8:00 A.M. – 8:10 A.M.

Workshop Welcome

8:10 A.M. – 8:55 A.M.

Historical Overview of Risk Analysis and Risk Management Systems

8:55 A.M. – 9:55 A.M.

Essentials for Premarket Risk Management Systems – Hazard Analysis and Risk Acceptability

9:55 A.M. – 10:35 A.M.

Exercise 1 – Risk Evaluation Matrix and Rationale

10:35 A.M. – 10:50 A.M.

Break

10:50 A.M. – 11:10 A.M.

Exercise 1 Review

11:10 A.M. – 11:40 A.M.

Correlating RMS Data for a Life-Cycle Approach

11:40 A.M. – 12:40 P.M.

Essentials of RM Data for Design Changes and Regulatory Submissions

12:40 P.M. – 1:25 P.M.

Lunch

1:25 P.M. – 1:55 P.M.

Exercise 2 – Design Changes – Submissions and ‘Letters to File’

1:55 P.M. – 2:15 P.M.

Exercise 2 Review

2:15 P.M. – 3:15 P.M.

Human Factors and Usability Across the Device Life-Cycle

3:15 P.M. – 3:30 P.M.

Break

3:30 P.M. – 4:00 P.M.

Exercise 3 – Life-Cycle Case Studies for Human Factors

4:00 P.M. – 4:20 P.M.

Exercise 3 Review

4:20 P.M. – 4:40 P.M.

Closing Session – Key Takeaways – Resources – and Thank You!

2023 MedCon Workshop Facilitators

Bill Brodbeck

STERIS Corporation

Shannon Hoste

Agilis Consulting Group

Kim Trautman 

MEDIcept

Brian Siroka

MEDIcept

Tina Krenc

KTA Compliance Consulting

Because of the generosity of our supporters, we can continue our work to improve the healthcare products industry.

Abbott, sponsor

Diamond Sponsor

Zimmer Biomet, sponsor

Platinum Sponsor

Steris, Sponsor

Platinum Sponsor

Eli Lilly, sponsor

Gold Sponsor

Johnson Johnson, sponsor

Gold Sponsor

Learn more about supporting MedCon 2024 through sponsorship by contacting Patrick Flynn at +1-301-770-2920, ext. 246, or pflynn@raps.org.

This conference is co-sponsored by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services. The contents are those of the presenters and do not necessarily represent the official views of, nor an endorsement by, FDA/HHS or the U.S. government.