Guides

From user needs to CE marking: why traceability isn't optional

In MedTech, every requirement must exist for a reason. That reason ...

Here are 12 practical tips for improving design control in MedTech product development.

Especially useful if you're managing requirements, verification/validation tests, ...

How to classify your medical device software per IEC 62304?

Not all software is equal.

IEC 62304 defines 3 software safety ...

Traceability connects ISO 14971 and IEC 62304.

Without it, risk control is incomplete.

Risk management only becomes meaningful when each identified risk ...

Traceability isn’t just for the final review. It’s a daily tool for safer, smarter and compliant SaMD development.

In software development, ...

You have a CAPA process. But is it connected to your risk management & design controls? Let’s start with the ...

IEC 62304 doesn’t prescribe your doc formats. But it does expect you to connect the dots.The standard does not impose ...

Risk management is not complete without traceability, ISO 14971 is clear on risk management process we need to implement:

• Risk Analysis

• Risk ...

A simple, visual breakdown of a very not-simple standard: IEC 62304

IEC 62304 defines the software life cycle requirements for medical ...