Greenlight Guru Medical Device Blog

Get the latest updates from our blog:

Top 30+ Medical Device Conferences You Should Be Attending in 2018 - Featured Image

Top 30+ Medical Device Conferences You Should Be Attending in 2018

If you’re looking to land your company's next big deal, keep up on the latest regulatory trends, for...
How to Integrate Complaint Handling and Risk Management - Featured Image

How to Integrate Complaint Handling and Risk Management

Did you know that complaint handling continues to be a big reason medical device companies receive 4...
Challenges with Applying Risk Management Throughout the Manufacturing Process - Featured Image

Challenges with Applying Risk Management Throughout the Manufacturing Process

Today we’re going to be taking the topic of risk management to the next level. We are talking to Jim...
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?
Common Mistakes That Can Tank Your FDA 510(k) Submission - Featured Image

Common Mistakes That Can Tank Your FDA 510(k) Submission

Do you know the percentage of 510(k)s that are rejected by the FDA the first time? Shockingly, it’s ...
What is Software as a Medical Device (SaMD)? - Featured Image

What is Software as a Medical Device (SaMD)?

Medical devices are a big business covering a wide range of modalities and applications. To ensure t...
Understanding How to Use Real-World Evidence for Medical Device Regulatory Decisions - Featured Image

Understanding How to Use Real-World Evidence for Medical Device Regulatory Decisions

The topic of Real-World Evidence is generating a lot of discussion lately, especially after the draf...
Here Are the 4 Types of FDA Inspections You Need to Understand - Featured Image

Here Are the 4 Types of FDA Inspections You Need to Understand

Every medical device manufacturer knows that, at some point, they should expect the FDA to arrive to...
Greenlight Guru Extends Platform with New Product, Grow, to Streamline PostMarket Quality Processes - Featured Image

Greenlight Guru Extends Platform with New Product, Grow, to Streamline PostMarket Quality Processes

The only eQMS specifically for medical device will enable companies to move beyond baseline complian...
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 doz...
How to Prepare for the Medical Device Single Audit Program - Featured Image

How to Prepare for the Medical Device Single Audit Program

  How is your understanding of the Medical Device Single Audit Program (MDSAP)?

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...