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Regulatory & QM TOOLS

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We help you to document properly.

What do I have to document in order to meet regulatory requirements? This question concerns all medical device manufacturers. We have developed a variety of tools in the form of templates, forms or pre-populated templates, which demonstrates compliance with regulations, standards or guidelines. We can offer you the following efficient tools:

Templates, Forms and pre-populated Templates

  • Audit-Checkliste Companion Document MDSAP (Deutsch)
  • Audit Checklist Companion Document MDSAP (English)
  • Checkliste Grundlegende Anforderungen gem√§√ü Richtlinie 93/42/EWG (Deutsch)
  • Essential requirements checklist according to Directive 93/42/EEC (English)
  • Checkliste Grundlegende Sicherheits- und Leistungsanforderungen gem√§√ü Verordnung (EU) 2017/745 (Deutsch) (NEW)
  • General safety and performance requirements checklist according to Regulation (EU) 2017/745 (English) (NEW)
  • Inhaltsverzeichnis Technische Dokumentation gem√§√ü Verordnung (EU) 2017/745 (MDR) (Deutsch) (NEW)
  • Table of contents for technical documentation according to Regulation (EU) 2017/745 (MDR) (English) (NEW)
  • Klinische Bewertung gem√§√ü MEDDEV 2.7-1 Rev. 4 (Deutsch)
  • Clinical evaluation according to MEDDEV 2.7-1 Rev. 4 (English)
  • Qualit√§tssicherungsvereinbarung mit H√§ndler (Deutsch)
  • Quality Assurance Agreement with distributor (English)
  • Qualit√§tssicherungsvereinbarung mit Produktions-Lieferanten (Deutsch)
  • Quality Assurance Agreement with Production Suppliers (English)
  • Quality Assurance Agreement with representatives in Australia (English)
  • Quality Assurance Agreement with representatives in Brazil (English)
  • Quality Assurance Agreement with representatives in Japan (English)
  • GAP Analysis Clinical Evaluation according to MEDDEV 2.7-1 Rev. 4 versus Regulation (EU) 2017/745 (English) (NEW)
  • Vergleichs-Analyse QMS-Anforderungen der Verordnung (EU) 2017/745 versus ISO 13485:2016 (Deutsch) (NEW)
  • GAP Analysis QMS Requirements of Regulation (EU) 2017/745 versus ISO 13485: 2016 (English) (NEW)
  • Many more

Please feel free to contact us. We will gladly email you our complete range of tools.

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