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Top 3 Reasons for FDA 483 Observations in 2020 - Featured Image

Top 3 Reasons for FDA 483 Observations in 2020

By Etienne Nichols on September 12, 2021
The US Food and Drug Administration (FDA) has released the quality system inspection data for citati...
Top 3 Most Cited Issues in Medical Device Inspections from FDA FY2020 - Featured Image

Top 3 Most Cited Issues in Medical Device Inspections from FDA FY2020

By Nick Tippmann on June 14, 2021
What did FDA report as the most-cited issues during medical device inspections for the fiscal year o...
Understanding and Handling Different Types of Feedback - Featured Image

Understanding and Handling Different Types of Feedback

By Nick Tippmann on January 14, 2021
What’s the relationship between product feedback, complaints, and adverse events? 
Free Complaint Template for Medical Devices - Featured Image

Free Complaint Template for Medical Devices

By Jon Speer on October 21, 2020
One of the major post-market responsibilities of medical device companies is handling customer compl...
Greenlight Guru Introduces Quality Event Automation to Advance Efficiencies in the Management of Post-Market Quality Events - Featured Image

Greenlight Guru Introduces Quality Event Automation to Advance Efficiencies in the Management of Post-Market Quality Events

By Nick Tippmann on October 19, 2020
New capability automates the quality event process through customized templates that increase effici...
Unannounced Audits: A Survival Guide for Quality Managers - Featured Image

Unannounced Audits: A Survival Guide for Quality Managers

By Jon Speer on August 16, 2020
We’re in an industry that requires preparation. Unlike less regulated industries, there’s an expecta...
How to Build a QMS for a Medical Device - Featured Image

How to Build a QMS for a Medical Device

By Nick Tippmann on July 8, 2020
Where do you begin when building a quality management system (QMS) for a medical device? It’s a task...
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

By Jon Speer on July 5, 2020
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)

By Taylor Brown on February 9, 2020
As leaders of medical device companies, our goal is always to create devices that are safe and effec...
How to Integrate Complaint Handling and Risk Management - Featured Image

How to Integrate Complaint Handling and Risk Management

By Jon Speer on December 5, 2017
Did you know that complaint handling continues to be a big reason medical device companies receive 4...
How to Streamline the Customer Complaint Handling Process - Featured Image

How to Streamline the Customer Complaint Handling Process

By Jon Speer on November 27, 2017
It can be quite nerve-wracking the very first time your medical device company receives a complaint ...
What Does a Risk-Based QMS Mean? - Featured Image

What Does a Risk-Based QMS Mean?

By Jon Speer on October 1, 2017
What exactly is a risk-based QMS?

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