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Guides
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 ...
Building medical device software? It's not just about IEC 62304.
To implement medical device software, manufacturers must deal with a layered ...
The Definitive Guide to Medical Device Connectivity
Considerations on the path to connecting a medical device to the cloud.
Interested in connecting ...
Completing design changes and maintaining a comprehensive design history file (DHF) are critical aspects of the Design Control process, particularly ...
Staying ahead of regulatory requirements, managing risks, and ensuring product quality can feel like an uphill battle.
Every day, resource ...
The Definitive Guide to Medical Device Connectivity
Creating and maintaining a comprehensive technical file for medical devices is essential for regulatory ...