u/Exact-Leg4755

Whether you work in medical devices, IVDs, pharma, or biotech...

What's one mistake or misconception you had when you first started in Regulatory Affairs or Quality?

Some examples:

• Misunderstanding FDA requirements
• Thinking ISO 13485 was "just documentation"
• Confusing verification vs. validation
• Writing ineffective CAPAs
• Underestimating risk management
• Missing the importance of design controls
• Something else entirely

What happened, and what lesson did you take away from it?

I always find real-world experiences far more valuable than textbook examples, and I'm sure others new to the field would too.

I'm curious about the learning curve in Regulatory Affairs and Quality.

For those working with medical devices, IVDs, pharma, or biotech:

What regulatory topic was hardest to understand when you started?

FDA requirements?

ISO 13485?

Risk management?

EUMDR?

CAPA?

Or was it something else entirely?