Should We Use Short Or Lengthy Templates For Medical Device Compliance?

We're a startup and currently looking for document templates for our medical device compliance. The OpenRegulatory templates seem to be...
Getting Started
May 22, 2024

How Much Does Medical Device Compliance Cost?

We're a startup and are considering bringing a medical device to market. How much does it cost?...
Getting Started
May 20, 2024

How Long Does Medical Device Compliance Take?

We're a startup and want to bring a medical device to market. How long does it take to get all...
Getting Started
May 20, 2024

Which QMS Software Should We Choose?

We're a startup developing software as a medical device and we're wondering which QMS software to choose. They all seem...
QMS Software
May 19, 2024

Can We Do Agile Development For Our Medical Device Software?

We want to do agile development. Can we do agile development for our medical device software?...
Technical Documentation
Agile Development
May 19, 2024

How To Do Medical Device Software Development?

Our company wants to get into medical device software development. How do we get started and how do we have...
Getting Started
May 17, 2024

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

We're In A Rush. Can We Automate Our Technical Documentation Completely?...
Technical Documentation
ChatGPT
Confluence QMS
Jira QMS
May 17, 2024

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...
Quality Management
Post-Market Surveillance
May 14, 2024

Should We Register Our Algorithm As a Patent?

We’re developing software. Should we patent our algorithm?...
Getting Started
Digital Health Business Strategy
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...
Clinical Evaluation
April 11, 2024