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Robyn Scopis
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Robyn Scopis

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A new week, a new to-do list to tackle. Any regulatory projects we can assist with? Nothing like crossing items off the list as handled!
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Robyn Scopis

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I know that lately I have been re-posting a lot myself, but am wondering why so much seems to be re-posts. Either that or people post a link to another page. I view G+ on my mobile and it is difficult to always be clicking on secondary links. When this G+ started, most of my follows were original postings and opinions. What has changed? Maybe it is the people I follow. Maybe the usage of G+ has changed. Maybe the original content is private and not public for the top interesting posters. I am not sure and just wanted to throw it out there.

(And before anyone says it, I know that you get out what you put it and I have minimal original posting myself.)
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Robyn Scopis

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The equation of science to other aspects. Amazing.
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Amazing is right. Seems like its all linked in one way or another.
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Happy 11:11:11 on 11/11/11!!
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It is interesting how the international community is excited about this. We need to keep in mind that it only received an IDE to perform the clinical trial. That is no guarantee that it will succeed or gain full and final FDA approval. I do have to admit, it will be a fun story to watch!
Andrea Kuszewski originally shared:
 
Suspended Animation Is FDA Approved and Heading To Clinical Trials

Suspended animation is an experimental technique that could buy critically injured patients the crucial extra time needed for surgeons to save their lives. Dr. Peter Rhee, chief of Tucson, Arizona’s trauma center is one of several pioneers behind a growing push to graduate suspended animation from experimental vetting to common treatment. He’s getting there. The Food and Drug Administration has already approved his technique for human trials, and he has secured funding from the Army to conduct the feasibility phase. Dr. Rhee is currently lobbying for funds to conduct a full trial. If he’s successful human trials could begin as early as next year.
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Have her in circles
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Robyn Scopis

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Amazing! I hope McDonalds contacts him over all this.
 
Wow.  This is going to be a HUGE story:  

"Physical assault by McDonald's for wearing Digital Eye Glass" 

Choice quote:  "Subsequently another person within McDonalds physically assaulted me, while I was in McDonand's, eating my McDonand's Ranch Wrap that I had just purchased at this McDonald's. He angrily grabbed my eyeglass, and tried to pull it off my head. The eyeglass is permanently attached and does not come off my skull without special tools."

http://bit.ly/OCJoVr
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Robyn Scopis

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A great opportunity to see another amazing event!
 
This Tuesday/Wednesday will be last Transit of Venus in this CENTURY - next in 2117. Don't miss it!

And before it happens again, the Earth will change beyond recognition

It won't happen again until December 2117. On June 5/6th, 2012, Venus will transit the face of the Sun in an event of both historical and observational importance. The best places to watch are in the south Pacific, but travel is not required

Check on map where will be visible → http://goo.gl/H6uXr
Watch NASA video → http://goo.gl/IphN6
See picture from the last transit → http://goo.gl/tCESk

→ SHARE TO EVERYONE ←
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Robyn Scopis

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Happy Tuesday to everyone! Have a great week. 
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The FDA has been reviewing the submission process over the past couple of years. Finally we are starting to have some drafts released and products re-categorized. It will be interesting to see how this plays out through the actual submission process, especially placing it in the light that the FDA reviewers just received re-training. How do you think this new process will affect the review process?
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Even with the FDA considering regulations on new technology and its relationship to the definition of medical device, many are still trying to tie their technology to the iPhone. Getting your medical device into the Apple store would be a huge boost to any marketing campaign. This is a great article discussing the aspects of getting into the Apple store.
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Have her in circles
928 people
Aberdine Miquela's profile photo
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Glenda Burell's profile photo
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Introduction
Mother, Wife, 
Business Owner, Medical Device Regulatory consultant, 
WoW player and Alea Iacta Est member :)

Life is good...busy, but good!

I grew up in Irvine, CA and since 1992 I have been associated with the medical device regulatory community.  In 2008 I became partner at Regulatory Specialists, Inc.  Before that, I worked in-house full time at client's facilities.  One was to assist with establishing a new ISO13485 system, and the other was to run a regulatory department that was in the middle of a PMA.

Right now, I am building Regulatory Specialists into a full service regulatory consulting firm.  You can visit us at www.regulatoryspecialists.com (stay tuned, we are updating the site currently).  We can also be found socially at Google+ (Robyn Scopis) and the Medical Device Regulatory Circle.  Also, we are on Facebook (Regulatory Specialists).

Becoming partner has changed my life and lets me keep in touch with medical device innovators all over the world.  I am always astounded at the new inventions we are involved with.

I am also the mother of a daughter who is 2.  She amazes me and keeps me on my toes on a daily basis.  Watching your child grow up is the best gift in the world.

Please visit some of my links to see more about me and Regulatory Specialists, Inc.  Feel free to contact me at robyn@regulatoryspecialists.com anytime you have a quick question or would like assistance.

I freely give out my cell phone (949-422-3853) and do respond to calls.  I live in Fullerton, CA and would love to meet up to discuss work if you are in town and I am available.

Always do right. This will gratify some people, and astonish the rest.

Mark Twain (1835–1910)
American writer

Bragging rights
Partner at the largest medical device consulting firm on the west coast.
Robyn Scopis's +1's are the things they like, agree with, or want to recommend.
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