Michelle Lott, a RAPS member who recently worked with RAPS to create our new RAPS Online University course series: How to Conduct a Regulatory Pathway Assessment Series says that regulatory pathway assessment is “really the building block of a regulatory strategy.”
It emphasizes that all medical device products can go through these steps to reach commercialization and focuses on how to submit various presubmission types to FDA and special considerations for their use.
Read our full interview with Michelle here!
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Brooke Keith
Marketing
Denver CO
United States
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