The basis of your device CERs is Literature Search. If you’re in charge of compliance for a number of goods, you’re well aware that EU MDR presents a significant challenge to your team and current timeframes. If you’re a smaller manufacturer, you’re probably just dealing with one or two people who are responsible for all things regulatory and quality.
Larger businesses have bigger staff, but they also have a lot more items to service. Budgets are being slashed, and deadlines are being reduced. Many of the larger companies we deal with are already having trouble keeping up with their Assessor’s remarks.
MDR has imposed an undue burden on firms to meet year after year. You have various alternatives as a writer or regulatory manager in order to finish all of your submissions on time (and correctly)
It’s also not only a matter of meeting deadlines. Reports that are rejected can be thrown together by anyone. We make a living by submitting reports that aren’t returned with a list of revisions or scrutiny from the notified authority.
What you actually need are entries that are so well-written and structured that they breeze right through the NB’s review procedure. When a Clinical Evaluation Report is denied, we frequently discover that the Literature Search was of poor quality.
The I3CGlobal method is meant to relieve your team of unnecessary responsibilities, allowing them to focus on review and overall submission.
Advantages working with experienced consultants and writers
MDR’s responsibilities are cumbersome, crashing down on already overburdened and unappreciated Regulatory and Quality departments. To ensure accuracy, verified data, and a high-quality readable product, I3CGlobal chooses to utilise a talented result-oriented team of medical writers with a world-class database and special software. All of this is done at a 40% lower price than a competitor.
Our staff have the expertise and tools necessary to ensure that a 500-page dense research paper is error-free and legible by Notified Body assessors with regulatory submission experience.