Hear R&Q and Other Industry Experts Discuss 510(k) Submissions at AdvaMed's Workshop In Irvine, CA

Join R&Q's Marilyn Waxberg and Nancy Morrison as they speak along with other industry experts at AdvaMed's 510(k) Submissions Strategy Workshop in Irvine, CA this month. The event is scheduled for two days: February 22-23.

Marilyn is R&Q's Senior Principal Advisor and Nancy is Director of Regulatory Affairs. Nancy will be speaking to The Law and Regulations portion of the agenda alongside Pamela Forrest of international law firm King & Spalding. Both Marilyn and Nancy will be leading the Strategy and Planning section on day two.

What?

When?

Where?

Agenda

• The legal basis for a 510(k): The potential consequences of not submitting a 510(k)
• Different types of 510(k)s
• How to determine if a 510(k) is needed
• How to select the appropriate type of 510(k)s
• The Paradigm 513(g)'s

Startegy and Planning
Marilyn Waxberg, Senior Principal Advisor, R&Q
Nancy Morrison, Director of Regulatory Affiars, R&Q

• Factors to consider when developing a strategic and regulatory plan
• How to define the role of the regulatory professional
• How to use FDA guidance when planning and organizing the 510(k)
• General vs. specific use
• Pre-Submission meetings
  
  

Where to sign up?

Find the 510(k) Submissions Workshop in Irvine, CA at the link above and register!

I can't make it to California. Now what?

Ah, we have you covered! Download our guide for clearing a 510(k) at the link below. It's the next best thing to being there in person. By following the 10 steps outlined in our white paper, you'll be on your way to an efficient and effective submission process in no time.