MDR Compliance

Medical Devices Regulation - Clinical Evaluation - Celegence

MDR Compliance

Celegence team has extensive experience writing Clinical Evaluation Plans & Reports, including comprehensive literature reviews.

Our team uses a proprietary technology, CRCP (Celegence Regulatory Compliance Platform), to streamline our MDR compliance and medical writing services. The Celegence team has extensive experience writing Clinical Evaluation Plans & Reports, including comprehensive literature reviews. With a thorough knowledge of all aspects of CER writing, we offer an unparalleled end-to-end solution.

Our system allows your team to streamline all aspects of your CERs and avoid constant revisions. This not only improves efficiency but allows for quality assurance and oversight from your RA project manager throughout the entire process.

We write the highest quality Clinical Evaluation Reports, faster.

Celegence - Client Trust - Life Science Regulations

Compliance

Every device company has to adhere to the EU MDR, with complexities varying based on the device classification, type, therapeutic area. This means your regulatory staff must expend substantially more time and energy to make sure every aspect of your CER submission compliant. We leverage our technology to expand the compliance capabilities of your team by reducing the time spent on current activities while simultaneously amending your process to ensure compliance with the new MDR regulations. With live editing, project management, and alerts, our team will keep all contributors on track. This means your first submission will be fully compliant with a faster turnaround with your Notified Body.

EU MDR - Regulatory Compliance Productivity - Celegence

Productivity

Medical Device manufacturers’ resources are stretched thin due to the time consuming nature of the entire process of writing CERs, but especially with respect to literature review and adverse event analysis. This inherently tedious element of CERs typically results in hours of labor intensive work from your writing team. At Celegence, our CRCP data gathering tool is able to significantly reduce the amount of time needed to complete literature research. Paired with our expert services, our technology allows our team to work cohesively to guarantee timelines are met, reduce your cost and improve overall efficiency.

Celegence - Innovation - Life Science Regulations

Quality

The bottom line of all MDR documentation will always be the quality and breadth of your final written product. Our technology assures the completeness of your documentation as per regulatory requirements, which will be accepted by your Notified Body. Features such as version control of your source documentation and the final report, alerts to writers as data analysis changes, and grammar improvement tools will ensure 100% quality for each submission. With the oversight of our regulatory expertise and our advanced technology, your updated regulatory process will ensure all the boxes are checked for your device’s compliance. CRCP will hasten your process without any sacrifice in quality.

Are Your Regulatory Resources Equipped for the MDR?

With the recent delay of the EU MDR, Celegence has been proactive in supporting device manufacturers with getting their RA/QA departments ready for the DoA (date of application). We broadcasted a comprehensive webinar that outlined the most pertinent issues surrounding the transition from MDD to MDR. You can read more about our webcast that included a panelist from a Notified Body as well as numerous Regulatory executives.

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