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Consultants Network

Consultants' Network - Medical Device Development: Standards and Guidance and Rules, Oh My!

on September 11, 2017 from 6:00 PM to 8:30 PM

Speaker Warren Craycroft
Topic Info

Monday, September 11, 2017

IEEE Consultants’ Network of San Diego

Topic: Medical Device Development: Standards and Guidance and Rules, Oh My!

Speaker: Warren Craycroft.

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.





Speaker Bio

 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.

Location Giovanni's Restaurant, 9353 Clairemont Mesa Boulevard at Ruffin Road, in Kearney Mesa
Directions 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 bigger map.
 

Agenda 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 second Monday 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 PM. The 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.
Cost No charge. Buy your own dinner.
RSVP No RSVP needed. All are welcome, just show up. Bring two guests.

Questions: 
Alfonso Limon, 760-918-5730,
 alfonso.limon@oneirix.com.



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