Stephen Ostertag
How to prepare your medical device for FDA regulatory review: The Benefit-Risk Determination
FDA determines whether PMA (pre-market approval) applications or De Novo classification requests provide a “reasonable assurance of...
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Stephen Ostertag
- Oct 2
- 1 min
Bio on the Bayou: Medical and BioInnovation Conference in New Orleans
I'll be attending the upcoming Bio on the Bayou conference in New Orleans this October 03-04. This conference brings together academics,...
stephen2760
- Sep 11
- 2 min
Improving Trust and Health Care Use with Empathy Research: A Need for Health Care Providers
TIMBS Consulting provides research services in the medical and health care fields. One area we specialize in is what we call “Empathy...
stephen2760
- Sep 7
- 2 min
FDA Best Practices for Selecting Predicate Devices for 510(k) Submission
Today, September 07, 2023, the FDA issued their Draft Guidance for Industry and Food and Drug Administration Staff on best practices for...
stephen2760
- Aug 31
- 2 min
Future Directions in Medical Device Research: AI/ML and Cybersecurity
The future of medical device research is focused on two areas, AI/ML and Cybersecurity. This brief post focused on AI/ML. A second will...
Stephen Ostertag
- Aug 1
- 2 min
Formative Research and Medical Device Startups: Success through Smart Investments
Starting a medical device manufacturing company is a courageous endeavor. There’s potential for considerable pay-off, in helping those in...
Stephen Ostertag
- Jul 26
- 2 min
Formative Research and Start Up Medical Device Companies: Saving you Money, Time, and Embarrassment
Medical device startups (or any startups) are risky endeavors. The rewards of success can be many, but the chances of failure are great....
Stephen Ostertag
- Jul 5
- 3 min
TIMBS Consulting: Details and Purpose
Details: What is TIMBS Consulting TIMBS Consulting is a research company that conducts a variety of research in the medical and health...
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