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Medical Device Reporting (MDR): How to Take Advantage of Your Electronic Records - Featured Image

Medical Device Reporting (MDR): How to Take Advantage of Your Electronic Records

Some companies in the medical device industry show resistance to digital technology, preferring to u...
Understanding Post-Market Surveillance Requirements for Medical Devices (US & EU Markets) - Featured Image

Understanding Post-Market Surveillance Requirements for Medical Devices (US & EU Markets)

As leaders of medical device companies, our goal is always to create devices that are safe and effec...
FDA 21 CFR Part 820: 8 Most Common Mistakes to Avoid - Featured Image

FDA 21 CFR Part 820: 8 Most Common Mistakes to Avoid

If you’re a medical device company selling or planning to sell into the US market, you should be fam...
Everything You Need To Know To Perform Effective Root Cause Analysis - Featured Image

Everything You Need To Know To Perform Effective Root Cause Analysis

Picture this: something goes wrong with a medical device, and a complaint is issued. In a post-marke...
Is Your Medical Device Company CAPA Happy? - Featured Image

Is Your Medical Device Company CAPA Happy?

The medical device industry could be more proactive than reactive when managing systemic issues. We’...
5 Most Common Problems with your CAPA Process - Featured Image

5 Most Common Problems with your CAPA Process

Year after year, the corrective and preventive action (CAPA) process continues to be the most widely...
3 Real World Document Management Horror Stories - Featured Image

3 Real World Document Management Horror Stories

In the medical device world, it’s not uncommon to get hung up on documentation. “It takes too much t...
CAPA Process Mistakes You Want to Avoid - Featured Image

CAPA Process Mistakes You Want to Avoid

What are the most common problems for medical device companies with their CAPA process?
CAPA Process - Step-by-Step Instructions [Infographic] - Featured Image

CAPA Process - Step-by-Step Instructions [Infographic]

CAPA is an area that we talk about often, mainly because it’s still such a big issue for medical dev...
How to Streamline the Customer Complaint Handling Process - Featured Image

How to Streamline the Customer Complaint Handling Process

It can be quite nerve-wracking the very first time your medical device company receives a complaint ...
13 Steps to Creating a Risk-Based CAPA Process - Featured Image

13 Steps to Creating a Risk-Based CAPA Process

What does it mean to create a risk-based CAPA process? How should companies go about it?
Ultimate Guide to Corrective and Preventive Action (CAPA) for Medical Devices - Featured Image

Ultimate Guide to Corrective and Preventive Action (CAPA) for Medical Devices

  What Is This CAPA Guide About? As an experienced medical device professional who has worked with d...

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