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GxP Training Management Guide for Med Tech Companies

How to build a training management system that scales with your needs
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Key insights covered in the guide:

The FDA, EMA and ISO 13485 all expect documented evidence that every member of your team is properly trained to do their job, and fully up to date with current procedures. 

Not “trained once.”

Not “probably read the SOPs.”

But trained and tested, with documentary evidence to prove it.

But too many med tech teams still rely on spreadsheets, shared drives, or disconnected LMS tools that can’t prove who was trained, on what, or when. Regulators expect more: Structured processes, verified comprehension, and full traceability.

What ISO 13485, FDA QMSR, EU MDR, and ICH E6 require from your training records

The most common training-related failures that triggered FDA 483s in 2024

Why self-attestation isn’t enough - regulators expect demonstrated comprehension

What Good Training Practice looks like in scale-up environments

How to align your training process with SOP changes, document controls

What to look for in an LMS - and the features that create risk instead of reducing it

How to handle audit questions about training - before they’re asked

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