Start Here: The Blueprint for Certifying Medical Software

MDD Class I: Here's What You Have to Do Before May 2021

People You Need: Person Responsible for Regulatory Compliance, Safety Officer, Medical Device Consultants

Writing An Intended Use for Software as a Medical Device

Medical Device Classification

Choosing a Notified Body

Accessing Standards For Less Than 30€

Software Validation Procedure for ISO 13485 compliance?

How to Get a UDI (Unique Device Identifier) For MDR Compliance

How to Classify Software as a Medical Device Under the MDR? (MDCG 2021-24)

FMEA, Part 1: Risk Acceptance Matrix (ISO 14971 Risk Analysis)

ISO 14971 Walkthrough

Doing a Software Release in Compliance With IEC 62304

Software System Testing Based on the IEC 62304

Medical Device Software Architecture Documentation (IEC 62304)

Software Verification For Medical Device Software (IEC 62304)

Writing Software Requirements Based on the IEC 62304

Writing Technical Documentation

How to document SOUP for IEC 62304 compliance?

Writing a Software Development and Maintenance Plan for IEC 62304 Compliance

IEC 62304 Walkthrough

Clinical Evaluation Report (CER) For Medical Devices: 3 Easy Steps

QMS Software for Medical Devices (ISO 13485): The Ultimate Comparison

Do We Need a User Manual for Our Software as a Medical Device?

Should We Develop Our Software Or Set Up Our QMS First?

MDR Class 1 Devices: Do They Exist (as software)?

What's the Definition of a Medical Device According to the MDR?

Is Our Software a Medical Device (and Do We Need to Certify It)?

Do We Have to Read Those Boring Standards?

How Do SemVer Versions Map to Significant Changes for a Medical Device?

Software as a Medical Device: What's a Significant Change?

Machine Learning Software as a Medical Device: Can We Update Our Model?

Do We Have to Re-Do All Software System Tests After a Minor Change?

Can We Use GitHub and Other SaaS For Our Software as a Medical Device?

Should You Automate Your Software Architecture Documentation?

Do Auditors Read Your Code?

Do You Need Video Cameras For User Testing?

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

Software Validation Procedure for ISO 13485 compliance?

How to document SOUP for IEC 62304 compliance?