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

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

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

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)

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

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

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?

By Jon Speer on October 1, 2017

What exactly is a risk-based QMS?

Understanding the Connection Between Complaints, CAPAs, and MDRs

By Nick Tippmann on May 24, 2017

Today we are going to talk about the connection between complaints, CAPAs, and MDRs. They are all in...

What is a “Quality Data Source” for your CAPA Process?

By Jon Speer on April 17, 2017

There’s a phrase that the FDA states in their policies around CAPA, which elicits a few questions. T...

What Should Really Trigger a CAPA?

By Jon Speer on April 4, 2017

Over years of working with medical device companies, we’ve found that there is a particular area tha...

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.

4 Key Compliance Issues for Medical Device Companies

By Jon Speer on February 11, 2017

The goal for most creators of new medical devices is to be able to get them to market as quickly as ...

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