MHS Download Center
Application forms for management systems, medical devices

  1. A¡§Request for Technical Meeting
  2. B¡§ISO, MDD/IVDD,CMDCAS Certification related documents

¡ÚRequest for Technical Meeting¡Û
A-1
Request for Technical Meeting MH_SP_01.doc, Rev. 11
     
 

¡ÚISO, MDD/IVDD,CMDCAS Certification related documents¡Û
B-1
Request for Quotation Questionnaire MED_F_03.06E.doc, Rev. 9
  Applicable standard¡§ISO13485, MDD/IVDD
B-2
Application/Questionnaire ISOF-04e.doc, Rev.15
  Applicable standard¡§CMDCAS
B-3
Application for CE Conformity Assessment(QM)/Application for the certification of a Quality Management System (EN ISO 13485) MED_F_03.04E.doc, Rev. 17
Attachment 1 pdfMED_F_0304.01E.pdf, Rev. 0
  Applicable standard¡§MDD Annex V / II.3, IVDD Annex IV.3 / VII, ISO13485
Please make sure to read the attachment 1.
B-4
Application for CE Conformity Assessment (Product) MED_F_03.03E.doc, Rev. 15
Attachment 1 pdfMED_F_0303.01E.pdf, Rev. 0
  Applicable standard¡§MDD Annex III / II.4, IVDD Annex III / IV.4
Please make sure to read the attachment 1.
B-5
Application for Extension of EC-Certificates MED_F_03.10E.doc, Rev. 7
  Applicable standard¡§MDD, IVDD
B-6
Change Notification MED_F_09.04E.doc, Rev. 5
    Applicable standard¡§ISO13485, ISO9001, CMDCAS, MDD, IVDD
 
¡üReference¡§Approval of Significant Change pdfMED_F_09.05E.pdf, Rev. 3
B-7
Company Information Update Form MH_04.01E.doc, Rev. 7
  Applicable standard¡§ISO13485, ISO9001, CMDCAS, MDD, IVDD
B-8
Facility Information JPM_F_02.05E.doc, Rev. 3

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Fax : +81 3-3372-4122

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Links

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  2. Standard & directives
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  4. Links to regulations for Medical Devices worldwide
Contact us: Tel : +81 3-3372-4849 E-Mail:info@tuv-sud.jp