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HEALTHCARE AND MEDICAL DEVICES E-SSENTIALS

Your regular update for technical and industry information

New Service Model for Design Dossier Review

Time-to-market is an essential success factor. Regulations regarding class-III medical devices require a clearly defined review of the Design Dossier. Depending on the complexity of the product and the project – as initial certifications, change notifications or extensions of an existing certificate – the review process can become quite complex. The progress of a review strongly depends on the quality of the files or how critical the identified deficiencies are. This leads to a review process that is not fully predictable. However, it is possible to increase the efficiency of the workflow and with it minimize the process times. We are currently rolling out a new Design Dossier Workflow that supports an optimized processing of your projects. The workflow is built on 3 columns:

  • Advanced notice for optimal project planning and preparation
  • Defined review times for predictable results
  • Agreed time-lines for you to answer our questions

Advanced notice time of eight weeks supports an efficient project start from the moment you finished your documents. Involve us at an early stage of your project and give us the opportunity to finish contract review, quotation based on your details, order and scheduling of the first review cycle before you actually finish your Design Dossier.

Together with your quotation we propose a time-line for the first review cycle that fits to your project plan (typically 40 working days). After the agreed evaluation cycle you will either receive the message that the review is finalized and the evaluation by our certification body has started or you will receive a report containing our questions.

Following this question report we agree on a timeline for providing your answers to us so that the review team is ready for processing your project when you have improved your documentation.

All proposed time lines are considered as a basic service. Depending on our resources we are always happy to provide expedited services with accelerated time lines, flexibly tailored to your project plan and your needs.

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