Developing an FDA Regulatory Strategy

Our January 2020 webinar is designed to help you create a comprehensive regulatory strategy that enables you to successfully enter the US market.

In this two-part webinar series, R&Q presents the definitive resource for bringing your medical device to market in the United States. Part 1 of the series will address Class I and Class II devices, while part 2 will cover Class III devices and be scheduled for late spring.

Register for part 1 on this page and you'll be notified via email when part 2 is announced.

This webinar is not is a rehash of the regulations (we'll be sure to provide references, however).

We'll begin by looking at everything that needs to be included in a thorough regulatory strategy. While viewing the big picture can be daunting at first, it's a critical step to understanding the strategic process and formulating an efficient, cost-effective plan... that works.

Since executing everything at once is challenging, the webinar will not only cover what to do - like properly classifying your device and implementing your quality system - but also when to execute. It also takes into consideration questions such as, "What type of evidence do you need for a 510(k)?" and “What are the pros and cons for Q-subs? Finally, we'll look at potential pitfalls where we've seen clients misstep and how to avoid those situations.

Considering the challenges related to EU MDR, this webinar series may be especially helpful to European companies considering the US as a new market.