“There’s just not enough time to satisfy your Notified Body Reviewer…”
If you are a manager or executive responsible for getting your medical devices approved by your Notified Body, then you likely are facing some of these issues regarding your Clinical Evaluation Reports:
EU MDR has created a problem. Companies with multiple products must update their CERs to a new and far stricter standard. It simply takes too much time to update each template, and medical writing staff’s are drowning in work.
Many companies are attempting to hire an army of Medical Writers to fill the gaps in productivity and hit those crucial submission deadlines. Unfortunately everyone who attempts this experiences a few major challenges.
Before you hire another general CER Writer
The CiteMed process brings together silicon valley technologists and seasoned Regulatory Affairs Professionals to deliver the Clinical Literature Search and Review section of your CER. By using our process your team can benefit from: