NLP-Aided Clinical Evaluation Reports (CER) for Medical Devices.
Produce High-Quality CERs in a Fraction of the Time with CapeStart’s Natural Language Processing (NLP) and Subject Matter Expertise.
In an environment of ever-more stringent regulations, drafting a high-quality Clinical Evaluation Report (CER) is crucial – but also a labor-intensive process requiring specialized skills. CapeStart’s expert team and powerful NLP solution can generate submission-ready CERs compliant with MEDDEV 2.7/1 revision 4, MDR, and other guidelines faster and more effectively than a manual approach.
Major Challenges in the CER Process (and How We Solve Them).
Medical device makers must develop, submit, and regularly update CERs to get and stay compliant. But manufacturers often run into three main obstacles.
- Creating a compliant CER with sufficient clinical evidence is extremely time consuming
- Defining, analyzing, and documenting clinical data related to the safety and efficacy of medical devices is extremely difficult
- Finding the right mix of technical, clinical, and regulatory expertise to meet these requirements is often impossible (or extremely expensive)
But CapeStart can help. Our NLP-aided solution processes large volumes of unstructured data quickly and reliably, shrinking the time, cost, and effort required to identify and extract clinically relevant information.
CapeStart’s deep team of subject matter and machine learning (ML) experts have decades of combined knowledge around CER regulations, medical writing, literature screening, and data analysis combined with machine learning (ML) and NLP models and processes.
What’s the CapeStart Difference?
Regulator-Ready Documents
Receive submission-ready, polished documents created with the right language and formatting style, populated with the most relevant and accurate technical information.
Hawk-Eyed Quality Assurance
All documents undergo thorough and rigorous quality assurance checks to ensure the highest standard of language, formatting, and scientific accuracy.
Timely Document Delivery
All CERs, CEPs, and other documents are delivered when you need them – and not a second later – so you’re never scrambling at the last minute.
An Expert Team
Our deep bench of ML and NLP engineers, data analysts, regulatory experts, and medical writers have a wide range of clinical, scientific, and compliance experience.
Use cases.
Clinical Evaluation Plans.
CapeStart’s regulatory, technology, and medical experts can help build a Clinical Evaluation Plan (CEP) – a roadmap of your CER defining the scope, methodology, and criteria for an acceptable risk/benefit profile. CEPs for CE-marked devices should include relevant design, materials, or manufacturing changes along with recently identified clinical concerns.
Literature Search Using Active Learning.
Manual literature searches can be outright nightmares with poorly constructed keyword combinations (resulting in thousands of irrelevant hits). CapeStart’s NLP solution uses active learning to develop the most effective search protocol possible, identifying all relevant favorable and unfavorable data from valuable sources such as Pubmed, EMBASE, and Cochrane.
Clinical Evaluation Report Creation and Maintenance.
CapeStart's team of experienced subject matter experts and medical writers can help build, deliver, and keep up to date a comprehensive CER. The CER includes a benefit/risk profile and all relevant clinical evidence surrounding your medical device (and similar devices) to ensure conformity assessment certification and device approval.
Gap Analysis.
We’ll conduct a Gap analysis of recent regulatory requirements or updates, existing CERs based on similar products, and any missing or grey areas of technical documentation/evidence you’ll need for device approval, including specific requirements for clinical evaluation documents, data appraisal, and demonstration of equivalence.
Other Features and Benefits.
