MDR and IVDR

orangeglobal service package for MDR/IVDR implementation

orangeglobal –
is your adviser for substantiating your planning to market surveillance of your medical device in the local market.

 

THE SERVICE PACKAGE IN DETAIL: THE ASSIGNMENT:

  • Implementation of the entire range of services by experts – whether subtasks or full projects.
  • Facilitation of international market access. 
  • Preparation of a strategy that is efficient in terms of time and costs for practically relevant project realisation. 


THE SOLUTION PROCESS:

  • Feasibility and needs analysis (feasibility study) incl. consultation and clarification of the requirements.
  • International market research and strategic concepts as well as campaign development and adaptation by the Centre of Competence Marketing.
  • Clinical trials with a clinical protocol in accordance with ICH-GCP, ISO 14155 and MEDDEV 2.7.1 Rev. 4 to ensure seamless access to authorities.
  • Creation of the quality management system in accordance with ISO 13485 and GMP.
  • Completion of the technical documentation in accordance with the requirements of MEDDEV and ZLG.
  • Consideration of the benefit analysis over the course of the pre-market testing.
  • Preparation and translation of the instructions for use (IfU) and the readability testing and labelling of a medical device.
  • Preparation of eIfUs in accordance with Commission Regulation (EU) No. 207/2012.
  • Usability testing in accordance with Annex I of the MDR/IVDR.
  • Planning and testing of the usability/applicability of medical devices in accordance with the IEC 62366 standard.
  • Risk analysis and risk evaluation to provide evidence of the safety in accordance with DIN EN 62366 and ISO 14971.
  • CE certification, notifications, registrations and approvals in accordance with MDR 2017/745/EU and IVDR 2017/746/EU or MDD (93/42/EEC), AIMDD (90/385/EEC) or IVDD (98/79/EC).
  • Communication with the notified bodies of your choice
  • Reports to authorities during post-market surveillance.


YOUR BENEFITS:

  • Access to local markets around the globe. 
  • Enhanced quality and increased product, documentation and process security.
  • Cost reduction as a result of reduced labour and administration costs and more efficient coordination.
  • Shorter international time-to-market.



INTERNATIONALISATION OF MEDICAL DEVICES CONTACT PERSON:

Frau Dipl. Biol. Jana Wolkow
Project Manager Regulatory Affairs
Tel. +49 (0) 731 954 95 - 511
jana.wolkow@orangeglobal.(.)de