Greenlight Guru Medical Device Blog

Get the latest updates from our blog:

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)...
7 Common Mistakes That Can Delay Your FDA 510(k) Clearance - Featured Image

7 Common Mistakes That Can Delay Your FDA 510(k) Clearance

  The 510(k) clearance process is often met with a mix of trepidation and anticipation by medical de...
How Process Excellence Leads to Product Excellence - Featured Image

How Process Excellence Leads to Product Excellence

Today, we are talking to Mike Fisher, who is the director of product development at the Global Cente...
Debunking 8 Commonly Held CAPA Myths - Featured Image

Debunking 8 Commonly Held CAPA Myths

  CAPA is a source of ongoing issues within medical device companies.
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. If you’re confident that you have ev...
Looking to join a fun, fast growing SaaS company? greenlight.guru is hiring in all areas! - Featured Image

Looking to join a fun, fast growing SaaS company? greenlight.guru is hiring in all areas!

Are you a smart, talented and ambition individual looking to be surrounded by other elite performers...
Understanding FDA’s Proposed Conformity Assessment Pilot Program - Featured Image

Understanding FDA’s Proposed Conformity Assessment Pilot Program

Today on the Global Medical Device Podcast, we’ll be talking to Mike Drues, who is a frequent guest ...
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?
Design Validation vs. Clinical Evaluation: What’s the Difference? - Featured Image

Design Validation vs. Clinical Evaluation: What’s the Difference?

How confident are you when it comes to design validation? Does this always involve clinical evaluati...
5 Tips for Conducting Medical Device Management Reviews - Featured Image

5 Tips for Conducting Medical Device Management Reviews

When was your last company management review? If you’re left scratching your head, it either may not...
How to Define and Decode Your Design Inputs and Design Outputs - Featured Image

How to Define and Decode Your Design Inputs and Design Outputs

We’re looking at a topic that confuses a lot of medical device developers.
Technical File vs. 510(k) vs. Design History File: What Medical Device Developer Should Know - Featured Image

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

Sometimes it feels like you need to know an entirely new language to work in the medical device fiel...

The Greenlight Guru Medical Device Blog

Providing you actionable tips, best practices and insights for better medical device quality, compliance and product development.

Our Most Popular Posts

Topics

See More Topics...