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
What is a GS1? Shedding light on the UDI provider
What is GS1? And how do we get GS1 UDIs?...
August 9, 2023
What is IFA?
What is IFA? And what does it have to do with UDIs?...
August 9, 2023
What’s the Difference Between a Document and a Record?
What the hell is the difference between a document and a record?...
June 22, 2023