A resource for biotech and pharma teams that need trusted expertise.

What to Ask FDA About Human Factors in a Pre-Sub

Make every minute count with regulators: craft sharper Pre-Sub questions and surface key human factors risks. Our HF and regulatory teams help you surface pitfalls early and enter pre-submissions with sharper questions that make your business go faster.

MDMA FDA Forum

Presenting Sponsor

Washington, DC, USA

12-13, March 2026

Nelson Labs Summit

Validation of Sterile Medical Devices

Frankfurt, Germany

24-26 February, 2026

Dana Point, CA, USA  |  16-20, March 2026

International Symposium on Human Factors & Ergonomics in Health Care

New York, NY, USA  |  22-25, March 2026

IVDR Transition Deadline: If You’re Behind, Catch Up Now!

Missed timelines don’t have to mean lost revenue. See practical paths to compliance and how to recover without starting over.

Don't Confuse Software with a System: The eQMS Trap

Buying eQMS software doesn't make a compliant Quality Management System. Don't let it put your regulatory approval and market success at risk.

Expansion Into Market Adjacencies: Unlocking Growth for the "Big Strategics"

Identify and pursue compelling adjacencies that balance strategic fit and acceptable risk, while creating long-term value.

High Reimbursement Implications: The CMS WISeR Model

CMS's Prior Authorization Demonstration could dramatically reshape Medicare reimbursement strategies for the medical device industry.

ISO 10993-1:2025 - Turn MDR Irritation Into Your Advantage

New biocomp standards might feel like regulatory overhead. Smart teams can use them to reduce testing costs and timelines.

Using Human Factors to Unlock Funding

High value, phased human factors testing unlocks funding while building regulatory compliance, solving the startup funding-validation paradox.