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EU Medical Device Regulations

European Union Medical Device Regulations

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  1. alexamine90

    OEM/PLM collaboration under the new MDR

    alexamine90, Apr 17, 2019
    Replies:
    0
    Views:
    912
    alexamine90
    Apr 17, 2019
  2. khamec

    Circumcision Device: Is it a Medical Device?

    khamec, Feb 22, 2017
    Replies:
    2
    Views:
    1,097
    Engr. Rashid Ali
    Mar 11, 2019
  3. Amy G

    Electronic Signatures

    Amy G, Oct 19, 2018
    Replies:
    1
    Views:
    182
    yodon
    Oct 19, 2018
  4. Amy G

    Article 12 Procedure Pack Labelling Requirements

    Amy G, Oct 2, 2018
    Replies:
    0
    Views:
    289
    Amy G
    Oct 2, 2018
  5. riri1912

    clinical evaluation

    riri1912, Feb 6, 2018
    Replies:
    0
    Views:
    908
    riri1912
    Feb 6, 2018
  6. Asquared

    Procedure for Clinical study

    Asquared, Jul 24, 2017
    Replies:
    3
    Views:
    579
    indicator
    Sep 7, 2017
  7. Irene

    INFO for notification/registration of medical device in UK

    Irene, Jun 30, 2017
    Replies:
    0
    Views:
    290
    Irene
    Jun 30, 2017
  8. emmamartsolf

    EU REACH compliance

    emmamartsolf, Jun 27, 2017
    Replies:
    1
    Views:
    368
    johnnymo77
    Jun 27, 2017
  9. HS330

    Research use only

    HS330, Dec 16, 2016
    Replies:
    1
    Views:
    580
    Vintage Goose
    Dec 16, 2016
  10. fialor

    Registration with MHRA

    fialor, Sep 6, 2016
    Replies:
    2
    Views:
    509
    fialor
    Sep 6, 2016
  11. JCIC49

    Revision of the MDD

    JCIC49, Aug 17, 2015
    Replies:
    19
    Views:
    3,546
    Xavier Canals-Riera
    Jun 22, 2016
  12. Anna Lee

    Recommendation for a book about the EU regulations

    Anna Lee, Jun 21, 2016
    Replies:
    0
    Views:
    554
    Anna Lee
    Jun 21, 2016
  13. khamec

    annex Za (Risk assessment)

    khamec, Jun 13, 2016
    Replies:
    1
    Views:
    527
    yodon
    Jun 13, 2016
  14. khamec

    Class III OBL STED format

    khamec, Jun 13, 2016
    Replies:
    1
    Views:
    757
    Vintage Goose
    Jun 13, 2016
  15. Walker

    Signing an Article 12 document

    Walker, May 9, 2016
    Replies:
    2
    Views:
    515
    Walker
    May 16, 2016
  16. QAengineer13

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

    QAengineer13, Apr 22, 2016
    Replies:
    3
    Views:
    626
    Monica
    May 5, 2016
  17. Jo Campbell

    EtO Sterilisation of Syringes

    Jo Campbell, Apr 29, 2016
    Replies:
    1
    Views:
    560
    Ronen E
    Apr 29, 2016
  18. Vintage Goose

    Registration of IVDs in Poland

    Vintage Goose, Apr 19, 2016
    Replies:
    2
    Views:
    583
    Vintage Goose
    Apr 20, 2016
  19. QAengineer13

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

    QAengineer13, Apr 14, 2016
    Replies:
    3
    Views:
    815
    Ronen E
    Apr 15, 2016
  20. Michelle Dempsey

    Declaration of Conformity 93/42/EEC

    Michelle Dempsey, Apr 13, 2016
    Replies:
    3
    Views:
    551
    Pads38
    Apr 13, 2016
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