In this episode, Don Pohl and Sheri Krajewski at NAMSA and Duane Mancini discuss ISO 10993 and biocompatibility testing for medical devices, the history of the standard and how it has evolved, why following the risk-based approach is becoming more important, tips to avoid having your submission delayed with various regulatory bodies across the globe, common mistakes and so much more.

Don Pohl LinkedIn

Sheri Krajewski LinkedIn

NAMSA LinkedIn

NAMSA Website

Duane Mancini LinkedIn⁠⁠⁠

⁠⁠⁠Project Medtech LinkedIn⁠⁠⁠

⁠⁠⁠Project Medtech Website

Mittal Consulting

Rook Quality Systems

Kymanox

In this episode, Omar Khateeb at Khateeb & Co. and Duane Mancini discuss carrying the bag, growth marketing, talking to investors, meeting with early adopters, his podcast The State of Medtech, speed learning, building loyal customers and so much more.

Omar Khateeb LinkedIn

Khateeb & Co. Website

State of Medtech Podcast

⁠Duane Mancini LinkedIn⁠⁠

⁠⁠Project Medtech LinkedIn⁠⁠

⁠⁠Project Medtech Website

In this episode, Kristen Mittal and Mridul Mittal at Mittal Consulting and Duane Mancini discuss their unique backgrounds in medtech, why they started Mittal Consulting, what medtech companies should expect from a regulatory strategy report, breakthrough designation, 513(g) vs. pre-submission meetings, common pitfalls, their advice for entrepreneurs, and so much more.

⁠Kristen Mittal LinkedIn⁠

⁠Mridul Mittal LinkedIn⁠

⁠Mittal Consulting LinkedIn⁠

⁠Mittal Consulting Website ⁠

⁠Duane Mancini LinkedIn⁠

⁠Project Medtech LinkedIn⁠

⁠Project Medtech Website