Consultants' Network - Medical Device Development: Standards and Guidance and Rules, Oh My!
on September 11, 2017 from 6:00 PM to 8:30 PM
Monday,September 11, 2017
IEEE Consultants’ Network of San Diego
Topic: Medical Device Development: Standards and Guidance and Rules, Oh My!
The field of regulated medical device development can be
quite daunting to the neophyte and the experienced practitioner alike. The magnitude of standards, regulations, and
guidance can appear to be a burdensome overhead that at best must be endured
and at worst, gamed and minimized. In
this talk, the speaker offers a different view: that medical device regulation is a
compilation of valuable lessons learned that have the same real-world
legitimacy as fire safety and building codes. We’ll look at the history of the current
regulatory environment, tracing its roots to past accidents and recalls, and
discuss the ever-increasing volume of regulation as a knowledge management
problem to be eagerly embraced, rather than a burden to be endured.
Warren Craycroft has nearly 30 years of experience in
medical device development in research and development, quality assurance, and
regulatory affairs roles in start-up medical device companies. A recurring theme in these roles has been
establishing a culture of quality assurance and regulatory compliance in these
small-headcount emerging companies.
Giovanni's Restaurant, 9353 Clairemont Mesa Boulevard at Ruffin Road, in Kearney Mesa
9353 Clairemont Mesa
Boulevard at Ruffin
Road. Giovanni's Restaurant (also called Giovanni's Pizza) is conveniently
located near the Interstate 15, SR 163 and SR 52 freeways. Please see the map
at www.ieeeconsultants.com. Click the little map on the web site for a
San Diego IEEE Consultants' Network Meeting Date and Time:
September 11, 2017 (Monday)
6:00 - 7:00 pm – Dinner and informal networking
7:00 - 8:30 pm – Round table discussion
We meet on the secondMonday
of every month, same time, same place (now at Giovanni's Restaurant in Kearney
Mesa). The format is dinner and networking from 6-7 PM and meeting from 7-8:30
presentation will start promptly at 7:00 PM. This will allow the formal portion
of the meeting to be finished no later than 8:30. All are
welcome to stay later for additional questions and networking.
We always welcome newcomers
and old faces we haven’t seen in a while. No RSVP is required; just show
up. Order at the counter; tell them you are with IEEE and they will direct
you to the meeting room. We now meet in the larger, quieter room, down the hall
to the right as you enter the restaurant.
No charge. Buy your own dinner.
No RSVP needed. All are welcome, just show up. Bring two guests.