CER / CEP Writing
Clinical Evaluation Plans & Reports
A Clinical Evaluation Report includes a culmination of both clinical data as well as relevant scientific literature to signify your device is safe, acts as intended, and is ready to be brought to the market. Our Clinical Evaluation writing team can provide end to end documentation that will assuredly satisfy the relevant Notified Bodies. We specialize in numerous aspects of CER writing that many RA teams are not able to produce internally, like literature reviews, as well as data support for Clinical Trials and Post-Market Surveillance. Our customizable consultative support is proficient in recent regulatory changes, like MDR, and can make sure your existing devices are prepared for the transition.
Our proprietary technology allows us to streamline all the components of your Clinical Evaluation Plans and Reports.
Our team uses proprietary technology to improve our efficiency, quality, and compliance in writing Clinical Evaluations. Our proprietary technology allows us to streamline all the components of your Clinical Evaluation Plans and Reports. We understand the time sensitive nature of the coming transition to MDR, and with our solution, we can alleviate the burden of updating your CERs as well as producing complete Reports for devices you intend to bring to the market soon.
At Celegence, we have an in-house team with extensive Clinical Evaluation writing experience. Our expertise ranges globally and can provide you with specific services based on your particular Therapeutic Area, Classification of the device, and Notified Body requirements.
Systematic Literature Review:
The risk and benefits portion of your medical device analysis must be drawn from existing clinical evidence through a Scientific Literature Review. This allows for two objectives, the first being to gauge the current risk that the device poses, and second, to be able to identify any knowledge gaps that must be addressed in the Clinical Evaluation Period.
Our extensive writing capabilities also include the following:
- Complete end-to-end CER/CEP writing and consultation
Literature Search and Review
Response To Questions (RTQs)
Clinical documents such as Protocols
From consultative services to end-to-end writing capabilities, our expert team can support you in all aspects of your Clinical Evaluation.
Reach out to learn more!