Us! Regulatory and Quality Solutions (R&Q)
A presentation and networking event over lunch addressing how an accessory or tool, in reality, is often a medical device.
This session will discuss combination products and the use of accessories with drugs and biologics. We will review examples of product types that may not be obvious and also what to watch out for during the development process. Finally we'll look at some MDR examples where the device types were not initially disclosed or identified correctly.
Thursday, March 10, 2016 from 11:30 AM to 1:00 PM (EST)
Massachusetts Biotechnology Council (MassBio)
300 Technology Square, 8th Floor
Cambridge, MA 02139
11:30 - 11:45am
Arrival and networking
11:45am - 12:30pm
Presentation and lunch (high-quality boxed lunch provided)
12:30pm - 1:00pm
Q/A and networking
Christine Santagate, RAC - Client Solutions Advisor, R&Q