Diagnostics for the Real World Ltd

• DE/CA70 - Landesamt für Umwelt- und Arbeitsschutz
  GermanyContact the authority →

Devices placed in 1 country

• XI2

4 contacts identified

• NL
  NADALA Lourdes

  PRRC
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• TK
  TRAN Katrina

  PRRC
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• TRAN Katrina
  Devices must conform to ISO 13485, harmonized standards, and national regulations before release. Technical documentation and EU declaration of conformity must be up-to-date. Post market surveillance must comply with Article 10(9) of Regulation 2017/746. Reporting obligations in Articles 82-86 of the 2017 IVDR must be fulfilled. For performance studies involving risks, the statement in Section 4.1 of Annex XIV (Regulation 2017/746) must be issued.
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• HARVEY Adam
  Devices must conform to ISO 13485, harmonized standards, and national regulations before release. Technical documentation and EU declaration of conformity must be up-to-date. Post market surveillance must comply with Article 10(9) of Regulation 2017/746. Reporting obligations in Articles 82-86 of the 2017 IVDR must be fulfilled. For performance studies involving risks, the statement in Section 4.1 of Annex XIV (Regulation 2017/746) must be issued.
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• QMD Services GmbH — 3 certificates — DRW
• Medical Technology Promedt Consulting GmbH — represents — DRW
• NADALA Lourdes — DRW
• TRAN Katrina — DRW