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Translations for Regulatory Affairs of medical devices and IVDs


The process of translation management at mpü for the registration of medical devices and IVDs is aimed at timely and error-free implementation of your projects.

This includes compliance with the guidelines of the competent Notified Body. Our range of services includes support for the following procedures and tasks during and after registration:

European requirements


  • Symbol templates in accordance with current requirements/recommendations (ISO 15223:2013-02)
  • ISO standards IFU:IEC 82079:2012
  • DIN EN 60601-1, ISO 17664, 15986 (medical devices containing phthalates)
  • Preparation of instructions for use (IfUs) in compliance with WHO specifications
  • IMDRF guidelines (labelling and instructions for use for medical devices)
  • Review of national requirements of the authorities such as HAS, ANSM, etc.
  • Review of MDD requirements from 93/42/EEC and 90/385/EEC or the new Medical Device
    Regulation (expected publication 2017), 98/79/EEC or EN ISO 13485
  • Manufacturer’s information: EN 1041
  • DIN EN 60601-1, ISO 17664, 15986


USA Vorgaben


  • CFR Title 21
  • Food and Drugs: Parts 801, 809, 812, 820, 830 & 1010
  • FD&C Act Sec 510(k) bzw. (modular) pre-Market Approval
  • FD&C Act Sec 519(a): Medical Device Reporting
  • Recognized Consensus Standards
  • Occupational Safety and Health Administration
  • Device Labeling Guidance #G91-1 (blue book memo)
  • Regulatory Requirements for Medical Devices FDA 89-4203
  • "Write it right" und "Human Factors Principles for Medical Device Labeling" (Companion Document)
  • Guidance on Medical Device Patient Labeling
  • MDUFA Section 206
  • MDTCA – Electronic Labeling
  • 510(k)-Verfahren, PMA, PuR

 

 

Translations for regulatory documents


Depending on the type of document, the translation processes are adapted and carried out taking into account both quality and time management and regulatory requirements. Below is an excerpt of the most common types of documents:

  • Summary Technical Documentation (STED
  • Usability Tests
  • Gebrauchsanweisung, Gebrauchsinformationen
  • Regulatorische und wissenschaftliche Gutachten etc.