[Virtual] Quality Systems for Medical Device Design and Development

​Tuan Le Mau, Ph.D from PASCALL Systems, Fall 24 cohort, will be hosting a roundtable on ISO 13485:2016 Quality Systems for Medical Device Design and Development 

​If you're building a medical device startup, you’ve probably faced the question: Should we outsource to an ISO 13485-certified CMO, or invest in building our own quality system from scratch? What criteria should guide that decision—and what are the tradeoffs?

​At PASCALL, we chose to build our ISO 13485 QMS in-house using cloud-based tools like Jira and Confluence. We've successfully maintained certification for over five years, and our system has supported the design and development of an FDA-cleared product (both hardware and software and algorithm). Along the way, we’ve learned a lot—both from things we did right and mistakes we’d avoid next time.

​This roundtable will be an open, tactical conversation. We'll share best practices, frameworks, tools, and cultural practices that have worked for us, as well as common pitfalls to watch out for. If you’ve been through ISO 13485 certification yourself, we’d love for you to join and add your perspective—we’re hoping for an interactive session where we all learn from each other.

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​Earlier this year, Tuan shared NIH/SBIR Best Practices, folks reported it was really helpful, check out the recording of the session here: https://drive.google.com/drive/folders/1Ti7B4X8joreFgLNeHyUWAqo6ZaprmRZK