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Translations for clinical evaluations and trials of medical devices and IVDs


As an ISO 9001 certified provider, mpü accompanies your multilingual documentation for translation and localisation processes throughout the following phases of your clinical trials and evaluations

 

  • Preclinical studies
  • Clinical trials of medical devices
  • Performance evaluation studies of IVDs
  • Post-marketing studies

 

It must be ensured that all data recorded in the study is correct and verified in all translation languages. Only then it is possible for the results from multinational trials to help with the launch of new diagnostic procedures, to influence and improve therapy recommendations and to guide innovative ideas through the registration process to find market acceptance.

For this reason, our translation management for clinical evaluations focuses on creating a process that ensures the correctness, legibility, completeness and plausibility of your documents and test conditions.

The test conditions comply with the standard use of the product and therefore the correct rendering into all translation languages is of critical importance for the safety, suitability and functionality in the clinical evaluation to ensure compliance with the laws and regulations.

 

Translations for all medical subject areas


Our range of services covers all subject areas such as

  • Gynaecology
  • Neurology
  • Oncology
  • Orthopaedics
  • Surgery
  • Radiology, etc.

 

thanks to the extensive experience our subject-matter experts have in these individual medical areas.

 

Different types of documents for
patients – investigators – authorities
require different processes


Because the different types of documents are intended for different target groups – patients/volunteers, investigators, authorities – the translations require different processes appropriate for the target group and the contents of the trial.

The interdisciplinary range of services offered by mpü means that we are able to translate and localise all types of documents appropriately for their multinational use, such as


Document types

 

  • Clinical trial protocols
  • Trial designs
  • Clinical investigational plans (CIP)
  • Treatment and observation plans
  • Patient information
  • Informed consent documents
  • Patient insurance documents
  • Survey forms
  • AE, SAE and SUSAR reports
  • Post-marketing surveillance
  • Periodic safety update reports
  • Field safety notices
  • Periodic summary reports
  • Trend reports
  • Documentation forms (CRF – Case Report Forms)
  • Statistical analysis plans
  • Documents for quality management
  • Trial master files (TMF)
  • Investigator study files (ISF)
  • Standard operating procedures (SOPs)

 

Translations for adverse event (AE), serious adverse event (SAE) and suspected unexpected serious adverse reaction (SUSAR) reports


Special 24-/48-hour service 

So that the time-sensitive reporting of AEs/SAEs/SUSARs can be ensured (24/48 hours), mpü has set up a special service. Our established and tested processes are oriented towards promptly preparing multilingual AE/SAE/SUSAR reports. The global position of our company and our experts means that we can make the most of different time zones so that this time-critical service can be offered.

All research questions within the clinical trial relating to safety, efficacy, clinical benefit, sensitivity, specificity, functionality and optimisation of application provide information about the properties of a medical device and its effects on patients and should therefore only undergo the most stringent, quality-based translation management processes for multilingual use.