Clinical Evaluation

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Is reduced time to triage via telemedicine a clinical benefit under MDR?

Anonymous • 2 comments

5 days ago

For telemedicine platforms that act as medical devices by generating data for review by a medical doctor (such as audio recordings of coughing or skin pictures), the goal is often to triage patients:

Accepted answer

I think you can definitely argue that reduced time to triage is a clinical benefit, since the MDR includes positive impact on patient management in it

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What Is a Clinical Development Plan?

Anonymous

updated about 1 year ago

We are writing the Clinical Evaluation Plan and need to include a Clinical Development Plan. What is that and is the difference to the Clinical Evaluation Plan?

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Accepted answer

Summarize all your clinical studies you conducted as well as all planned studies and investigation for your device. Provide a justification if you thi

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What Is Clinical Evidence (MDR)?

Anonymous

updated about 1 year ago

We are collecting data to write the clinical evaluation report for our software (class IIa). Our software uses an ML algorithm to detect anatomical structures in CT scans with accuracy of a radiologis

S

Accepted answer

If you need clinical data depends on your intended purpose (and the opinion of the auditor), the novelty of your device and yes, you can write of that