Rock the FDA Audit – by establishing a Great QMS!

Welcome to Episode 6 of Software Tech Talks – How the Pro’s Build Reliable Products.

Jan Dziewior is a highly experienced regulatory executive with over 25 years’ experience developing and expanding processes for product monitoring and complaint handling for medical devices. Her priorities include managing the complaint handling process in order to identify critical issues that impacted their medical devices, and ensure they’re mitigated quickly and systematically.

By always focusing on strict monitoring and reporting, her teams were highly effective in not only learning from mistakes made by others in the Industry, but also, applying those lessons learned to their quality engineering program – in order to continually promote a best practices culture.

More about Jan’s background:

Jan spent 12 years as an RN, where she specialized in critical care/trauma and she brings that real world experience to the medical device realm – where she’s performed in clinical, sales management, business development, marketing and quality roles.

Jan has held positions such as Senior Director of Infusion Clinical Services, VP Service Integration and VP Customer Master Data Programs – and we’re fortunate to have her time on this Interview.

Jan received her bachelors degree from the University of Viterbo in La Crosse, WI and currently resides in San Diego.  She has a passion for gourmet cooking, good wines and travel!

What Jan is an expert at:

Jan’s experience allows her to speak with authority to FDA Regulatory practices and Medical Device Manufacturing and Release in the US Market. Her knowledge is invaluable to those who are struggling with product quality issues or QMS implementation – either with products you’re trying to bring to market for the first time, or you’re dealing with painful Audits or Recalls – Jan has the answers you seek.

With Jan’s answers to highly important FDA and Regulatory Compliance Questions – we believe you should be able to establish a much strong QMS Process, which will contribute to you enjoying more reliable product releases.

Jan’s best book recommendation and why:

The Tipping Point by Malcolm Gladwell.  He uses great examples that everybody can relate to. It gets me thinking about smart technologies like the smart phone and the tablet – and how that evolution has found its way into medical devices, such as smart pumps, because that technology has made a huge difference in how we deliver care to our patients.

Bonus: send us a request, and we will send you Jan’s “Tips to Managing Customer Feedback & FDA Audits – Post Product Launch”.

These tips explain how to deal effectively with customer feedback, including recommended steps for highly successful FDA Audits – especially what NOT to do!

Send your request to: – Subject: FDA Tips


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