Which Data Should We Collect In Our Post-Market Surveillance?

We are an established manufacturer of a class IIb medical device software. Our software is a mobile app intended to analyze...
May 14, 2024

Should We Register Our Algorithm As a Patent?

We’re developing software. Should we patent our algorithm?...
April 21, 2024

What Is Clinical Evidence (MDR)?

We are collecting data to write the clinical evaluation report for our software (class IIa). Our software uses an ML...
April 11, 2024

How To Find Out Whether Your Regulatory Consultant Sucks

We’re working with a regulatory consultant but are not sure how capable they are. How to we find out whether...
April 3, 2024

How To Analyze And Report “Trends” Under The MDR?

We are setting up the PMS plan and according to the MDR Article 88 we need to report trends. We...
February 13, 2024

What Is a Clinical Development Plan?

We are writing the Clinical Evaluation Plan and need to include a Clinical Development Plan. What is that and is...
February 13, 2024

How Do We Certify API-Only Software As a Medical Device?

Our software only provides an API. We think it’s a medical device. How do we get it certified?...
February 7, 2024

What Is “FDA 21 CFR Part 820” Compliant eQMS Software?

We are a startup and are in the early stages of getting our medical device FDA approved. We are currently...
October 11, 2023

What’s the Minimum Number of Users for a Usability Test?

We’re planning our usability testing, i.e. our IEC 62366 - compliant Summative Usability Evaluation. Is there any sort of minimum...
September 7, 2023

What is a MDR UDI? Unraveling the Importance of Unique Device Identification

What is a UDI in the context of the MDR and FDA?...
August 22, 2023

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