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Nissim Shaked is appreciated, and has over 100 Karma points.Nissim Shaked is appreciated, and has over 100 Karma points.

Nissim Shaked Nissim Shaked is offline

Shaked

About Me

  • About Nissim Shaked
    Real Name
    Nissim Shaked
    Location
    Israel
    Public Email Address
    nissim.shaked@hotmail.com
    Company or School Name
    Operating in QA since 1984 & in Regulatory since 1994
    Company Product(s), Processes and/or Services
    Has hands on experiences in:
    *Regulatory & Quality requirements in Medical Device (class I, II and III)


    *Identify & implementation of standards needed for updated / new devices
    *Design Control according to FDA & MDD requirements
    *Design Verification & Validation (class I, II and III)
    *SW Validation
    *Process Validation
    *Risk Managment
    *Sterilization Validation (EtO,ג ,CO2)
    *Clean Rooms QA & RA Validation
    *Design transfer
    *Reliability & failure analysis
    *Statistical analysis
    *MDSAP (medi
    LinkedIn Page
    http://il.linkedin.com/pub/nissim-shaked/0/580/379

Statistics

Total Posts
Blog
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General Information
  • Last Time Logged In: 12th September 2018 07:31 AM
  • Registration Date: 15th February 2005
  • Referrals: 0

Friends

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Blog

Latest Blog Entry

Posted 25th March 2010 at 09:58 AM by Nissim Shaked Comments 14
I have just achieved Ordinance 169 approval form Japan (JMOH)
in my 1st attempt for Class IIa device
Recent Comments
I liked your web site...
Posted 17th November 2010 at 01:16 PM by arios arios is offline
[Link]...
Posted 17th November 2010 at 04:44 AM by Nissim Shaked Nissim Shaked is offline
Amazing!!!!, Congratulations...
Posted 5th August 2010 at 10:51 AM by arios arios is offline
They have found zero...
Posted 5th August 2010 at 03:52 AM by Nissim Shaked Nissim Shaked is offline
Baruch Hashem!
Posted 1st July 2010 at 09:22 AM by arios arios is offline

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