Questions About Getting Started
Can We Document Our Software After We’ve Developed It?
IEC 62304
June 3, 2024
Should We Use Short Or Lengthy Templates For Medical Device Compliance?
May 22, 2024
How Much Does Medical Device Compliance Cost?
May 20, 2024
How Long Does Medical Device Compliance Take?
May 20, 2024
How To Do Medical Device Software Development?
May 17, 2024
Should We Register Our Algorithm As a Patent?
Digital Health Business Strategy
April 21, 2024
How To Find Out Whether Your Regulatory Consultant Sucks
April 3, 2024
How Do We Certify API-Only Software As a Medical Device?
February 7, 2024
Should We Choose Our Cloud Provider Based on Free Credits?
May 30, 2023
Do We Need AI / Machine Learning Consultants?
May 24, 2023
Can We Bring a Lifestyle Device to Market First?
Digital Health Business Strategy
May 24, 2023
Should You Do a BfArM Classification Request? The Answer Is No.
MDR Class I
MDR Classification
November 15, 2022
As a MDR Class I Manufacturer, Should We Move to Hamburg or Munich?
MDR Class I
July 26, 2022
Should We Develop Our Software Or Set Up Our QMS First?
September 1, 2021
MDR Class 1 Devices: Do They Exist (as software)?
MDR Class I
August 31, 2021
What’s the Definition of a Medical Device According to the MDR?
July 29, 2020
Is Our Software a Medical Device (and Do We Need to Certify It)?
July 29, 2020
Do We Have to Read Those Boring Standards?
Accessing Standards
July 29, 2020