Why Is Literature Search So Crucial for a CER Writer?
Literature Search is the foundation of your device CERs. If your’e in charge of compliance on multiple products, then you also know that EU MDR poses a serious challenge to your team and your existing timelines. If you are a smaller manufacturer, you likely have only one or two folks tasked with all things regulatory and quality.
Larger companies have larger teams, but also exponentially more products to support. They also are facing tightening budgets and shortened timelines. In fact many of the larger firms we speak with are already struggling to keep up with their Assessor’s comments.
MDR has forced too great of a burden on manufacturers to comply with year after year. As a writing or regulatory manager you have several options in order to get all of your submissions completed on-time (and correctly)
And it’s not just a question of deadlines either. Anyone can slap together reports that get rejected. We’re in the business of submitting reports that don’t come back with a list of corrections and scrutiny from the notified body.
What you really need are submissions so thoroughly written and beautifully organized that they glide through the NB’s review process. We find that most often when a Clinical Evaluation Report is rejected, the Literature Search is of low quality.
The CiteMed approach is designed to obliterate the extra workloads for your team and enable them to focus on review and the overall submission.