greenlight.guru Medical Device Blog

Get the latest updates from our blog:

FDA Inspections and ISO Audits: What is the Difference? - Featured Image

FDA Inspections and ISO Audits: What is the Difference?

It’s every medical device manufacturer's favorite time… … the arrival of an FDA inspector or ISO aud...
How to Switch to eQMS Software When You’re Just Using Paper - Featured Image

How to Switch to eQMS Software When You’re Just Using Paper

  How reliable is your paper-based QMS system? This situation plays out in medical device companies ...
How Competitive Regulatory Strategy Differs from Regular Regulatory Strategy (And How to Use It to Your Advantage) - Featured Image

How Competitive Regulatory Strategy Differs from Regular Regulatory Strategy (And How to Use It to Your Advantage)

Have you ever considered the pros and cons of a PMA vs a 501(k)? Some of the considerations you must...
The Do’s and Don’ts of an FDA Inspection - Featured Image

The Do’s and Don’ts of an FDA Inspection

The FDA has arrived at your premises…
How to Translate Voice of Customer into User Needs - Featured Image

How to Translate Voice of Customer into User Needs

  How well do you do at capturing “voice of customer” and translating into user needs?
Comparing FDA Submission Types: 510(k) vs. De Novo vs. 513(g) vs. Pre-Submission - Featured Image

Comparing FDA Submission Types: 510(k) vs. De Novo vs. 513(g) vs. Pre-Submission

It can be confusing to know which submission type is the correct one for your particular development...
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...

The greenlight.guru Medical Device Blog

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