Clinical
Demonstrate your clinical evidence
Your device can save lives. We help you prove it.
We’ve helped over 100 companies on their clinical evaluation journeys.
We specialise clinical evaluation for all software medical devices, including health apps, SaMD and AI devices. From defining the Intended Use, clinical evaluation planning, systematic literature review, clinical investigation design, investigation reporting, to writing and maintaining your Clinical Evaluation Report through Post Market Clinical Follow Up, our specialist team is here to help you on your clinical evaluation journey. We work collaboratively and transparently, at a pace that suits you.
Your clinical investigations and clinical evaluation report support team
You can count on our qualified clinicians to provide you with exemplary assistance for your clinical evaluation report documentation, clinical investigational design, post market surveillance planning, medical affairs and publications.
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Software medical devices, including AI systems, need to provide a clinical benefit, and be able to demonstrate that benefit. The purpose of clinical evaluation is to conduct a logical and comprehensive assessment of your product’s ability to achieve that benefit safely and effectively.
Clinical evaluation starts before you build your product by defining an intended use and assessing the literature for that use case, conducting one or more clinical investigations, all the way through to post-market surveillance.
In a nutshell, you must be able to prove your claimed clinical benefit pre-market, and to ensure your software device remains safe and effective post-market. -
A Clinical Evaluation Report (CER) is a living document that is constantly being updated with clinical evidence, even after you’ve received regulatory clearance. It is broken down into several key documents:
Intended Use Statement (IUS)
Clinical Evaluation Plan (CEP)
Literature Review Report (LRR)
Clinical Investigation Plan (CIP)
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Most likely!
Clinical Investigations are mandatory for Class II and above software medical devices and AI systems, especially for novel technologies or use cases.
There may be some cases where an investigation is not required, for instance if claiming equivalence to another similar device where you have complete access to performance data from the predicate device.
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A systematic literature review is a vital part of demonstrating the scientific validity of your technology. A thorough review will put your company in a strong position for the rest of your clinical, economic and regulatory journey.
Conducting a thorough and systematic literature review can be intensive but is an essential part of the process. A systematic literature review involves following a pre-specified and reproducible search protocol allowing you to find and critically evaluate published scientific evidence relevant to your device. Being systematic in your approach is essential so that your review can be reproduced and updated regularly as new evidence becomes available.
A systematic review for medical device regulatory submissions is more extensive than an academic literature review, as you must also include regulatory database searches and competitor analysis.
Your systematic literature review should be updated at least once a year to include any new data regarding your medical device software, or that of your direct competitors, including any adverse event data.
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