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

FDA Inspections and ISO Audits: What is the Difference?

By Jon Speer on September 18, 2017
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

By Jon Speer on September 11, 2017
  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)

By Nick Tippmann on August 30, 2017
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

By Jon Speer on August 28, 2017
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

By Nichole Leahy-Glass on August 21, 2017
  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

By Nick Tippmann on August 18, 2017
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)

By Jon Speer on August 13, 2017
  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

By Jon Speer on August 8, 2017
  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

By Nick Tippmann on August 2, 2017
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

By Jon Speer on July 30, 2017
  CAPA (Corrective and Preventive Action) is a source of ongoing issues within medical device compan...
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

By Jon Speer on July 23, 2017
  So, the FDA is coming to inspect your medical device company. If you’re confident that you have ev...
Understanding FDA’s Proposed Conformity Assessment Pilot Program - Featured Image

Understanding FDA’s Proposed Conformity Assessment Pilot Program

By Nick Tippmann on July 21, 2017
Today on the Global Medical Device Podcast, we’ll be talking to Mike Drues, who is a frequent guest ...

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