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    •      - EN ISO 13485:2016



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    •      - Medical Device Directive (MDR)
    •      - Medical Device Directive (MDD)
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Medical Device Certification MDD
  • M.FR.08.15 - Planned Change Notification Form
  • FR.19.01 Confidentiality Declaration
  • FR.20.01 Impartiality Declaration
  • FR.23.02 Certification Rules & General Conditions
  • FR.24.01 Customer Complaint Objection and Advice Form
  • ISO 17021 Accreditaion Certificate
  • PR.09 Surveillance & Other Audits Procedure
  • PR.10 Certificates Suspention, Withdrawal & Notification Procedure
  • PR.11 Change of CB & NB Procedure
  • PR.21 Certificate & Brand Usage Procedure
  • PR.22 Audit Duration Determination & Planning Procedure
  • PR.23 Audit Fee Determination Procedure
  • PR.24 Appelas & Complaints Evaluation Procedure
  • PR.25 Certification Committee Work Procedure
  • PR.27 Control of Subcontracted Audit Activities Procedure
  • PR.31 Remote Audit Procedure
  • PR.32 Safety Procedure For Pandemic
  • TL.09.01 Significant Changes Indicated in Transitional Provision Defined in the Scope of MDR Article 120

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     - EN ISO 13485:2016
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