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crogroup

  1. FDA to Industry: Limit X-Ray Exposure to Pediatric Patients - new guidance issued today... fb.me/Ycj6L14W
  2. Glen Emelock presenting an update on Risk Management of Medical Device Software and EU Classification, today at... fb.me/20ZfWM04n
  3. CRO Group's Glen Emelock presenting today at ASQ/RAPS San Francisco Medical Device Software conference, Crowne... fb.me/1zpg28C4k
  4. FDA Guidance Provides Insight Into Risk-Benefit & deNovo Review Process bit.ly/I1iJkX fb.me/Yp7GcILi
  5. FDA issues Sex Differences Evaluation in Medical Device Clinical Guidance to solve female underrepresentation issue. fb.me/1q57iGXZ2
  6. Not able to attend last week's ASQ/RAPS FDA Update 2011? Synopsis and slides from the EU Update session here:... fb.me/PXGFcbKi
  7. CRO Group's Glen Emelock will be presenting 'EU MDD/IVDD' Update this week at ASQ/RAPS/MassMedic "FDA Update", 9... fb.me/T3Cu1j6H
  8. FDA Issues Risk Based Clinical Trial Monitoring Guidance: Recognition of Alternative Approaches to Frequent... fb.me/1cj14TJoY
  9. FDA to mobile medical app developers: "There's a (draft) 'Reg' for that" http://bit.ly/pXSpk0 http://fb.me/19uWFQzVz
  10. FDA issues draft Companion Diagnostic Guidance - Generally it will take 2 to Tango for Approvals in this 1st... http://fb.me/KHk9R0uP
  11. FDA releases Human Factors and Usability Testing guidance - cites cases when summary reports on this are expected,... http://fb.me/wRAN20io
  12. FDA Issues RUO/IUO Guidance - The Marketing 'Party' may be over. http://bit.ly/mEPMyf http://fb.me/C9jm56AO
  13. CRO Group client Neuronetics secures $30M in funding http://bit.ly/mGVyog http://fb.me/Rb6gLKOs
  14. We are currently looking for a part-time contract CRC/CRA for a consumer/OTC limited research study in the Boston area.
  15. Glen's BOSCON presentation, on April 12 will review EU Essential Requirements for Medical Device Software: http://bit.ly/gkU0dm
  16. CRO Group's Glen Emelock presenting at ASQ's BOSCON 2011 on MDD Technical File Reviews of Software and EN 62304... http://fb.me/KEYLFlOG
  17. What a long, strange regulatory trip it's been: FDA moves Medical Device Data Systems (MDDS) from Class III to... http://fb.me/LDaHhHGp
  18. Now with a link on Twitter and Facebook http://fb.me/DVXPJr4v
  19. FDA holds up on 510(k) changes - responds to Obama request, awaiting IOM report before adding new 510(k) requirements http://bit.ly/hpeNAH
  20. There may be a FDA Warning Letter for that...FDA looking into regulating medical related smartphone Apps. http://bit.ly/aGj1My