The Nemedio Blog:  Demystifying Compliance

your guide to product development and compliance for medical technology
Webinar - On Demand

The Compliance Journey, Part 1: Precompliance

September 1, 2021

On July 20, 2021, Nemedio hosted the first installment of the Compliance Journey Webinar Series. You can view a recording of that webinar here on demand.


You have an idea for a new medical device (maybe even a prototype). You’ve heard of words like “compliance,” “quality management,” and “regulatory affairs,” but you aren’t quite sure what they mean, and how or when to get started on implementing them at your company. During this talk, we will shed light on these and other compliance concepts. We will also provide you with a set of compliance activities that are appropriate for early stage companies, which will set you up for success as you transition to a full-blown compliance program when the timing is right for your company.

Learning Objectives

After this session, attendees should understand:

  • FDA device classification
  • Paths to FDA clearance
  • Quality management and quality management systems
  • How and why agile development teams can and should start quality and regulatory activities earlier than they think


  • Sabrina Varanelli, CEO
  • Sam Barberie, VP of Sales & Partnerships
  • Gilly Yildirim, Senior Project & Accounts Manager


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