Medical Device Quality, Regulatory and Product Development Blog | Greenlight Guru

Everything You Need To Know To Perform Effective Root Cause Analysis

By Jon Speer on July 14, 2019

Picture this: something goes wrong with a medical device, and a complaint is issued. In a post-marke...

5 Most Common Problems with your CAPA Process

By Jon Speer on February 10, 2019

Year after year, the corrective and preventive action (CAPA) process continues to be the most widely...

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

By Jon Speer on February 20, 2018

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

By Jon Speer on November 27, 2017

It can be quite nerve-wracking the very first time your medical device company receives a complaint ...

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 companie...

Better Root Cause Analysis for Safer, More Effective Medical Devices

By Jon Speer on May 8, 2017

Have you really figured out the root cause of any issues found in your medical device company? Root ...

Tips for Conducting Better Root Cause Analysis for Medical Device Companies

By Jon Speer on April 10, 2017

At some point, every medical device development company will encounter an issue that requires an inv...

Key Actions for Effective Customer Complaint Handling

By Jon Speer on March 14, 2017

Let's say, your medical device business has received a complaint from a customer.

9 Keys to Enacting CAPA for Medical Devices Following Your Internal Audit

By Jon Speer on February 28, 2017

Most of us really don’t get excited by the prospect of any kind of audit. The procedures, the paperw...

7 Steps to Respond to FDA 483 Inspection Observations (Response Template Included)

By Jon Speer on June 8, 2016

Attention: If you are a medical device company and you have class II or class III products registere...

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