PDA Midwest Dinner Event: Quantifying EU MDR Sterilization Deficiencies

PDA Midwest Dinner Event – April 28th, 2026

Sterilization Deficiencies

The PDA Midwest Chapter is pleased to host our April 2026 dinner event, featuring an exclusive behind‑the‑scenes laboratory tour and an in‑depth technical presentation at TÜV SÜD in New Brighton, Minnesota. This unique program offers attendees the opportunity to explore a leading testing and certification facility while gaining firsthand insights into the latest sterilization expectations, challenges, and regulatory trends.

Designed for professionals across the medical device and pharmaceutical industries, the event will highlight critical topics in sterilization science and compliance. Participants will learn how evolving regulatory frameworks—particularly under EU MDR and ISO standards—shape sterilization strategies, documentation requirements, and submission quality. Whether you are involved in product development, sterility assurance, validation, quality, regulatory affairs, or manufacturing, this event provides valuable knowledge to support robust and compliant sterilization programs

Agenda & Venue

Join us on 4/28, 2026 from 5:00pm – 8:30pm central time zone

Location

Presentation

Speaker

Michael Taylor – Medical Product Expert, TÜV SÜD

Michael Taylor holds a Master’s degree in Biomedical Engineering from Mercer University and brings extensive experience in medical device sterilization, technical assessment, and regulatory compliance. His background includes supporting terminal sterilization processes, sterility assessments, and technical documentation reviews for MDR, MDD, MDSAP, and ISO 13485 submissions.

Presentation Title

Quantifying EU MDR Sterilization (EO/IRR) Deficiencies: Lessons Learned

Abstract

Biological safety deficiencies in medical device submissions often lead to delays and substantial costs for manufacturers. This presentation delivers a quantitative review of TÜV SÜD‑issued sterilization deficiencies, focusing on requirements in EU MDR 2017/745 and the ISO 11135/11137 standards.

The session will highlight real-world data, trends by device class, and common pitfalls, particularly within EO and irradiation sterilization. Attendees will gain practical guidance to help reduce deficiencies and improve submission quality.

Topics Covered

1. Common Sterilization Deficiencies
   – Insights derived from actual device submissions, including EO, irradiation.
2. Regulatory Expectations & Best Practices
   – Interpretation of EU MDR 2017/745 and relevant ISO standards to support compliant sterilization documentation.
3. Streamlining Submissions
   – Overview of updated biological safety checklists and guidance for more efficient MDR submissions.

Registration

Registration includes*: Admission to networking/cocktail reception & full event access