RQM+ is a global MedTech service provider focused on accelerating compliance and market success. Through our unparalleled expertise and industry knowledge, we deliver specialized solutions and expedite the journey along the full product lifecycle for Med Device and IVD companies, from concept to commercialization to post-market.

Our portfolio of services enables the delivery of end-to-end solutions across the complete med device product lifecycle, with our: 
• Regulatory and Quality Consulting
• Lab Services (Jordi Labs)
• Clinical Trials
• Reimbursement
• Technology Solutions


RQM+

Overview

Response-factor variation is a core barrier to reliable quantitation in extractables and leachables (E\&L). This expert session focuses on **why response-factor accuracy matters downstream **and how Lumo’s predictive response factors make **toxicological risk assessment (TRA)** and regulatory dialogue more defensible, and when targeted experiments are still needed. We’ll keep the spotlight on decision quality, uncertainty handling, and practical boundaries for semi-quantitative work.

What you’ll learn

*   TRA impact: how tighter response-factor accuracy shifts margins of safety and escalation decisions.
*   Defensibility for regulators: documenting assumptions, uncertainty, and flags in the ISO 10993-18 context.
*   When predictions are enough: a clear rubric for moving from predictive results to targeted standards.
*   Real-world scenarios: representative compound classes (e.g., phenols, esters, acids, sulfur species) and what changes with better RFs.
*   Operational handoff: the deliverables RA/TRA reviewers need with semi-quantitative results.

Who should attend

E\&L scientists, RA/QA leaders, and toxicologists seeking decision-ready semi-quantitative data that stands up in submissions.

Panelists 

*   Ron Brown – Toxicologist, Risk Science Consortium
*   Ted Heise – Senior Regulatory Scientist, MED Institute
*   Kevin Rowland – Executive Vice President and General Manager of Lab Services, Jordi Labs, an RQM+ company
*   Yuanlin Deng – Senior Chemist II

*Certificate of attendance available upon request for live attendees.*
