Review for technical files
Notified Body-Like-Review for technical files
With the implementation of EU MDR and IVDR, manufacturers are encountering new hurdles, particularly in terms of Technical Documentation assessment. When submitting Technical Documentation to a Notified Body for review, you typically have 2 to 3 rounds of review to ensure your device is compliant. However, more often than not, the first submission can result in a long list of non-conformities, leading to delays and significant costs for your company, simply because the EU MDR has raised the required level of compliance.
Our experts can help
How can Qserve help?
The largest modification to technical documentation assessments under EU MDR and IVDR is that Notified Bodies need to evaluate all device classes equally in terms of breadth and depth. Previously, a sample of your technical documentation would have been examined, with reviewers highlighting the most important information in the time allotted to them for any device that wasn't class III (AIMDD or MDD) or class A (IVDD).
With Notified Body-Like-Reviews, our regulatory experts and former Notified Bodies employees will review your documentation before submission, mirroring the Notified Body approach and solving many issues that can be remediated.
By identifying and addressing any potential issues before submission, we can help you reduce the number of non-conformities, the burden of corrections and shorten the Notified Body review process and get your products CE marked.
Benefits of Qserve's Notified Body-Like-Review
- Your review will be performed by former Notified Bodies employees.
- As former Notified Bodies employees, our experts review.
- Our experts not only raise questions or address potential non-conformities, but also provide advice and support to resolve the issues. Save time and money during the conformity assessment phase.
- The tool was created through years of experience in reviews plus through position papers from BSI, DEKRA, TÜV SÜD, and TEAM-NB.
Interested in Qserve's Notified Body-Like-Review service?
Do you need assistance with a Notified Body-Like-Review for your technical files, or do you want to receive more information or advice? Qserve is here to help with your needs.