• Project Portrayals
  • Jobs
  • About us
  • EN EN EN en
  • DE DE DE de
Phone +49 521 950 220
Scriptor Dokumentations Service GmbH
  • Technical documentation
    • Editing text
      • Authoring
      • Legally compliant authoring
      • Updating documentation
      • Terminology
      • Writing optimised for translations
    • Authoring with Schema ST4
      • Text editing with SCHEMA ST4
      • Modular-based authoring
      • Information architecture + taxonomies
    • Images
      • Photos
      • 3D graphics
      • Illustrations
      • Screenshots
      • Editing images
    • Document layouts
      • Desktop publishing
      • Automated layout
    • Conceptual design
      • Editorial guidelines
      • Structural design
      • Layout design
      • Graphic design
      • Meta-data strategies
    • Analysis
      • IEC 82079-1
      • Machinery Directive 2006/42/EC
      • MDR + 2017-746
      • ANSI Z535.6
      • Directive 2014/35/EU
    • Optimising instructions
    • Documentation without words
    • Project management
  • Translations
    • Technical translations
    • Localisation
    • Terminology
    • Translating with SCHEMA ST4
    • Translations according to DIN EN ISO 17100
    • Language layouts
    • Translation management
  • Layout
    • Layout design
    • Layout templates
    • Desktop publishing
    • Automated layout
    • Language layouts
    • Documentation without words
  • Visualisation
    • Photos
    • 3D graphics
    • Illustrations
    • Screenshots
    • Editing images
    • 3D animations
    • Graphic design
  • SCHEMA ST4
    • Services for Quanos customers
    • Editorial services
    • Layout recall + publication
    • PLD + OMD templates
    • Migrating data
    • SCHEMA ST4 translations
    • Modular-based authoring
  • Consulting
    • Consulting for technical documentation
    • Consulting for translations
    • Consulting for SCHEMA ST4
  • Risk assessments
  • Search
  • Menu Menu
You are here: Technical documentation1 / Analysis2 / MDR + 2017-746

Manufacturers are obligated to implement the European Medical Devices Regulation (MDR) 2017/745 and the in-vitro Diagnostic Medical Devices Regulation (IVDR) 2017/746. This leads to more documentation work. The operating instructions are specified as a part of the product and must be presented as soon as the product is placed on the market.

Scriptor has been producing legally compliant operating instructions for large and medium-sized manufacturers of medical technology for decades (including for operating tables and heart-lung machines in accordance with Annex II of the MDR). Creating instructions for laboratory diagnostics has been one of our focal points since the nineties, and we are still active in this field today.

Analysis in compliance with MDR

Designed as a desk audit, the actual-state audit includes viewing the instructions for use with regard to the MDR 2017/745. We take the hazard class into account and adopt the results from the risk assessment. Furthermore, we assess whether the instructions are complete as stipulated by the directive. The MDR analysis, however, does not include a check for technical accuracy and completeness.

Authoring in compliance with MDR/IVDR

Authoring in compliance with the MDR or the IVDR, or adding MDR-relevant topics to the instructions (e.g. for product updates or after a revision of the regulation). Our experienced team can assist you with extensive product documentation, especially the operating instructions and service manuals. All this is available in both English and German, and with years of experience working on international teams.

Analysis in compliance with MDR

Designed as a desk audit, the actual-state audit includes viewing the instructions for use with regard to the MDR 2017/745. We take the hazard class into account and adopt the results from the risk assessment. Furthermore, we assess whether the instructions are complete as stipulated by the directive. The MDR analysis, however, does not include a check for technical accuracy and completeness.

Authoring in compliance with MDR/IVDR

Authoring in compliance with the MDR or the IVDR, or adding MDR-relevant topics to the instructions (e.g. for product updates or after a revision of the regulation). Our experienced team can assist you with extensive product documentation, especially the operating instructions and service manuals. All this is available in both English and German, and with years of experience working on international teams.

Scriptor highlights

  • Analysis of the instructions/manuals
  • Parallel authoring of user and service manuals
  • Authoring according to Annex 2 of MDR 2017-745
  • Updating of instructions/manuals
  • Translations

Scriptor highlights

  • Analysis of the instructions/manuals
  • Parallel authoring of user and service manuals
  • Authoring according to Annex 2 of MDR 2017-745
  • Updating of instructions/manuals
  • Translations

Your advantages

  • Directly implemented update specifications
  • Check and acceptance of the source documents
  • Subsequent translation

Your advantages

  • Directly implemented update specifications
  • Check and acceptance of the source documents
  • Subsequent translation

Address

Scriptor
Dokumentations Service GmbH

Krackser Strasse 12c
33659 Bielefeld
Germany

Tel: +49 521 950220
Fax: +49 521 9502225

e-mail: info@scriptor.de

Contact

Heike Hettwer
https://www.xing.com/pages/scriptordokumentationsservicegmbhhttps://www.linkedin.com/company/66207036/

Heike Hettwer

Managing Director
Scriptor Dokumentations Service GmbH

hettwer@scriptor.de

+ 49 521 950220

So finden Sie uns!

© Copyright - Scriptor Dokumentationsservice GmbH
  • Legal notice
  • Data privacy
  • GDPR Art. 13
  • GDPR Art. 14
Scroll to top