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NIEL’S Medical Device

As a digital AI-based assistant, NEIL’S Medical device supports Medical Device Industry in the creation of Clinical Evaluation of the Regulatory document and allows efficient review by competent authorities.

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An MDR compliant solution
Fit notified bodies requirements

With the transition from MDD to MDR, the medical device industry needs to demonstrate more clinical evidence which is a challenge for all CE marked devices on the market.

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Manufacturers will need to generate and provide more in-depth clinical data to prove safety and performance claims including tighter equivalency standards.

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The new regulation requires to most companies to update their clinical data.

Niel’s Medical device generates this additional clinical data with trusted evidence and automatic updates. A complete data cleaning in order to avoid any repetition which makes the extraction ready to analyse. Save time, effort, and make your clinical documentation approved by competent authorities.

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Niel’s Medical device generates this additional clinical data with trusted evidence and automatic updates. A complete data cleaning in order to avoid any repetition which makes the extraction ready to analyse. Save time, effort, and make your clinical documentation approved by competent authorities.

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A user friendly platform
Refocus your time on expertise

Niel’s Medical Device tool gains time on added-value research and allows to concentrate on reading and writing your regulatory CER documents

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Regular automated updates identifying new references for renewal clinical documentation or other literature review purposes

Features adapted to Medical device specificity
to meet CER expectations

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Define together project perimeter

Project scope: e.g. device name, device type, information about device of interest, intended use, therapeutic area, classification.
Topics by default: reviews, patient population, preclinical studies, contraindications, medical device vigilance (related adverse events), claims, performance, device longevity, benefits & risks, case studies.

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Get access to Niel’s Medical Device app

Ready-to-use space to explore selected documents.

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Review suggested keywords

Keywords list generated by AI is used by the user to refine documents selection.

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Explore relevant scientific articles list

In average about 100 articles for each C.E.R project.
Display of descriptive information (e.g Authors, date of publication, database, relevance).

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Access to full text article from the platform

Open access articles are available by default.
Restricted access articles are searchable according to your subscription.

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Get extraction of phrases of interest for writing

Direct access to a sentences list proposed by our AI technology (title and abstract content for all articles – Full text content from restricted articles need a subscription).
Review and select relevant sentences to draft your document.

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Access to a formatted document

Automatic creation of a draft with selected sentences.
Structured document following a predefined table of contents.

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Additionnal features

Notifications by push literature uptades (news articles for the reniew).
Traceability on literature appraisal.
Collaborative workflow for multi-users account.

Contact us
Learn more about NIEL’S Q-Analytics

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