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EU Medical Device Regulations

European Union Medical Device Regulations

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  1. khamec

    Class III OBL STED format

    khamec, Jun 13, 2016
    Replies:
    1
    Views:
    1,276
    Vintage Goose
    Jun 13, 2016
  2. Walker

    Signing an Article 12 document

    Walker, May 9, 2016
    Replies:
    2
    Views:
    1,014
    Walker
    May 16, 2016
  3. QAengineer13

    RoHS 2( 2011/65/EU) Lab instrument compliance date?

    QAengineer13, Apr 22, 2016
    Replies:
    3
    Views:
    1,331
    Monica
    May 5, 2016
  4. Jo Campbell

    EtO Sterilisation of Syringes

    Jo Campbell, Apr 29, 2016
    Replies:
    1
    Views:
    1,157
    Ronen E
    Apr 29, 2016
  5. Vintage Goose

    Registration of IVDs in Poland

    Vintage Goose, Apr 19, 2016
    Replies:
    2
    Views:
    1,175
    Vintage Goose
    Apr 20, 2016
  6. QAengineer13

    2014/35/EU ( LVD Directive) Compliance for IVD ?

    QAengineer13, Apr 14, 2016
    Replies:
    3
    Views:
    1,697
    Ronen E
    Apr 15, 2016
  7. Michelle Dempsey

    Declaration of Conformity 93/42/EEC

    Michelle Dempsey, Apr 13, 2016
    Replies:
    3
    Views:
    1,088
    Pads38
    Apr 13, 2016
  8. lola parra asensio

    Class Im auto-certificate or not

    lola parra asensio, Jan 29, 2016
    Replies:
    9
    Views:
    2,506
    Ronen E
    Feb 2, 2016
  9. Nicky

    Authorised rep question

    Nicky, Jan 29, 2016
    Replies:
    2
    Views:
    1,104
    Nicky
    Jan 29, 2016
  10. MarkMeer

    Notified Body Debacle

    MarkMeer, Jan 25, 2016
    Replies:
    14
    Views:
    3,573
    Ronen E
    Jan 27, 2016
  11. Jo Campbell

    Additional Notified Body

    Jo Campbell, Oct 15, 2015
    Replies:
    6
    Views:
    1,775
    pdzip
    Jan 22, 2016
  12. Sing Wee

    CE mark submission

    Sing Wee, Jan 8, 2016
    Replies:
    3
    Views:
    1,250
    pdzip
    Jan 22, 2016
  13. Jo Campbell

    Extension to Scope

    Jo Campbell, Jan 14, 2016
    Replies:
    2
    Views:
    964
    Jo Campbell
    Jan 15, 2016
  14. VinayN

    Regulatory Affairs Certification (RAC) from RAPS - is it really worth it?

    VinayN, Jan 3, 2016
    Replies:
    1
    Views:
    7,238
    Jim Hagenbaugh
    Jan 5, 2016
  15. Jon Cook

    Technical File - machinery directive/PPE directive

    Jon Cook, Nov 24, 2015
    Replies:
    5
    Views:
    1,567
    Steve Kent
    Nov 26, 2015
  16. Jo Campbell

    ETO Sterilisation

    Jo Campbell, Nov 13, 2015
    Replies:
    2
    Views:
    815
    Jo Campbell
    Nov 23, 2015
  17. Ronen E

    Cost indication for EC IVD design examination

    Ronen E, Nov 12, 2015
    Replies:
    0
    Views:
    720
    Ronen E
    Nov 12, 2015
  18. Achaos

    Biological Evaluation acc. to ISO 10993-1

    Achaos, Aug 29, 2015
    Replies:
    11
    Views:
    2,463
    jojo63
    Oct 16, 2015
  19. Jo Campbell

    Company name change and product labelling

    Jo Campbell, Oct 9, 2015
    Replies:
    2
    Views:
    1,018
    Jo Campbell
    Oct 13, 2015
  20. Jo Campbell

    Changing the classification of a medical device

    Jo Campbell, Oct 5, 2015
    Replies:
    8
    Views:
    1,422
    Jo Campbell
    Oct 6, 2015
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