Our company wants to get into medical device software development. How do we get started and how do we have...

We're In A Rush. Can We Automate Our Technical Documentation Completely?...

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

We’re developing software. Should we patent our algorithm?...

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

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

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

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

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

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