crogroup
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FDA to Industry: Limit X-Ray Exposure to Pediatric Patients - new guidance issued today...
8:19 PM May 10th
via Facebook
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Glen Emelock presenting an update on Risk Management of Medical Device Software and EU Classification, today at...
8:54 AM Apr 25th
via Facebook
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CRO Group's Glen Emelock presenting today at ASQ/RAPS San Francisco Medical Device Software conference, Crowne...
7:51 AM Apr 20th
via Facebook
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FDA Guidance Provides Insight Into Risk-Benefit & deNovo Review Process
7:24 AM Apr 19th
via Facebook
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FDA issues Sex Differences Evaluation in Medical Device Clinical Guidance to solve female underrepresentation issue.
1:21 PM Dec 16th, 2011
via Facebook
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Not able to attend last week's ASQ/RAPS FDA Update 2011? Synopsis and slides from the EU Update session here:...
11:30 AM Dec 12th, 2011
via Facebook
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CRO Group's Glen Emelock will be presenting 'EU MDD/IVDD' Update this week at ASQ/RAPS/MassMedic "FDA Update", 9...
2:29 PM Dec 4th, 2011
via Facebook
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FDA Issues Risk Based Clinical Trial Monitoring Guidance: Recognition of Alternative Approaches to Frequent...
7:23 PM Aug 29th, 2011
via Facebook
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FDA to mobile medical app developers: "There's a (draft) 'Reg' for that"
4:39 AM Aug 1st, 2011
via Facebook
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FDA issues draft Companion Diagnostic Guidance - Generally it will take 2 to Tango for Approvals in this 1st...
10:24 AM Jul 18th, 2011
via Facebook
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FDA releases Human Factors and Usability Testing guidance - cites cases when summary reports on this are expected,...
7:28 AM Jul 1st, 2011
via Facebook
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FDA Issues RUO/IUO Guidance - The Marketing 'Party' may be over.
2:53 PM Jun 5th, 2011
via Facebook
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CRO Group client Neuronetics secures $30M in funding
8:31 PM May 16th, 2011
via Facebook
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We are currently looking for a part-time contract CRC/CRA for a consumer/OTC limited research study in the Boston area.
8:09 AM Apr 8th, 2011
via Facebook
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Glen's BOSCON presentation, on April 12 will review EU Essential Requirements for Medical Device Software:
8:48 AM Mar 25th, 2011
via web
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CRO Group's Glen Emelock presenting at ASQ's BOSCON 2011 on MDD Technical File Reviews of Software and EN 62304...
8:37 AM Mar 25th, 2011
via Facebook
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What a long, strange regulatory trip it's been: FDA moves Medical Device Data Systems (MDDS) from Class III to...
3:14 PM Feb 27th, 2011
via Facebook
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Now with a link on Twitter and Facebook
10:50 AM Jan 25th, 2011
via Facebook
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FDA holds up on 510(k) changes - responds to Obama request, awaiting IOM report before adding new 510(k) requirements
9:57 AM Jan 25th, 2011
via web
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There may be a FDA Warning Letter for that...FDA looking into regulating medical related smartphone Apps.
6:51 PM Sep 9th, 2010
via web
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- Name The CRO Group, Inc.
- Web http://crogroup.com
- Bio FDA Approvals, Clinical Trials, QSR, ISO 13485, CMDCAS, CE Mark, 21 CFR 11, EU Rep, FDA U.S. Agent medical device, biotech, IVD and web based clients
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