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7 Problems with a Paper-Based Design History File (And How to Avoid Them) - Featured Image

7 Problems with a Paper-Based Design History File (And How to Avoid Them)

If you’re using a paper-based system to manage your design history file (DHF), it can raise several ...
How to Retroactively Create Design Controls and DHF (Even Though You Should Never Let This Happen) - Featured Image

How to Retroactively Create Design Controls and DHF (Even Though You Should Never Let This Happen)

So, you haven’t completed your design controls or design history file (DHF)...
How to Prepare Your Design History File (DHF) for an FDA Inspection - Featured Image

How to Prepare Your Design History File (DHF) for an FDA Inspection

  So, the FDA is coming to inspect your medical device company.
13 Common Pitfalls to Avoid During Medical Device Product Development - Featured Image

13 Common Pitfalls to Avoid During Medical Device Product Development

Are you falling into some of the common traps that surround medical device product development?
Technical File vs. 510(k) vs. Design History File: What Medical Device Developers Should Know - Featured Image

Technical File vs. 510(k) vs. Design History File: What Medical Device Developers Should Know

Sometimes it feels like you need to know an entirely new language to work in the medical device fiel...
Acronyms You Need To Know When Evaluating Medical Device Software Solutions - Featured Image

Acronyms You Need To Know When Evaluating Medical Device Software Solutions

Ah, yes! You aspire to run your device company in a paperless environment. Allowing you to capture a...
15 Items Medical Device Startups Need to Address - Featured Image

15 Items Medical Device Startups Need to Address

As a medical device startup, there are many things you are juggling and balancing all day, every day...

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