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.
Dokumentations Service GmbH
Krackser Strasse 12c
Tel: +49 521 950220
Fax: +49 521 9502225
+ 49 521 950220