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ISO 13485 & MDSAP Deadlines are Fast Approaching (And You Need a Notified Body) - Featured Image

ISO 13485 & MDSAP Deadlines are Fast Approaching (And You Need a Notified Body)

In less than four months, come March 2019, the transitional period for medical device companies to c...
Streamlining The Device Marketing Authorization Process - Featured Image

Streamlining The Device Marketing Authorization Process

There are a few additional steps to take when it comes to the Medical Device Single Audit Program (M...
ISO 13485 - Ultimate Guide to Quality Management Systems (QMS) for Medical Devices - Featured Image

ISO 13485 - Ultimate Guide to Quality Management Systems (QMS) for Medical Devices

            TABLE OF CONTENTS Overview Evolution of Quality Systems General Requirements Documentati...
FDA Aligning to ISO 13485:2016 (and Why It Matters) - Featured Image

FDA Aligning to ISO 13485:2016 (and Why It Matters)

Earlier this year, the FDA announced their intentions to change the US’s current medical device regu...
How Priority Designs Used Greenlight Guru to Gain ISO 13485:2016 Certification - Featured Image

How Priority Designs Used Greenlight Guru to Gain ISO 13485:2016 Certification

We have many different types of companies using Greenlight Guru to help them create a compliant qual...
How SOLIUS Went from Scratch to an eQMS and ISO 13485:2016 Certification - Featured Image

How SOLIUS Went from Scratch to an eQMS and ISO 13485:2016 Certification

It can be challenging for small companies to navigate the medical device regulatory pathways, especi...
Sneak Peek Into the ISO 14971 Revision Process (From a Member of the Standard's Working Group, JWG1) - Featured Image

Sneak Peek Into the ISO 14971 Revision Process (From a Member of the Standard's Working Group, JWG1)

The ISO Technical Committee TC 210 Joint Working Group 1 (JWG1) is a committee that reports to not o...
Tips, Tricks & Best Practices for Complying with ISO 13485:2016 - Featured Image

Tips, Tricks & Best Practices for Complying with ISO 13485:2016

When it comes to ISO 13485:2016, are you scrambling to meet requirements? Are you trying to figure o...
Timeline to ISO 13485:2016 (And Why You Need to Act Today) - Featured Image

Timeline to ISO 13485:2016 (And Why You Need to Act Today)

To be blunt, if your company has put off doing anything about ISO 13485:2016, you need to act immedi...
Understanding the New Requirements for QMS Software Validation in ISO 13485:2016 - Featured Image

Understanding the New Requirements for QMS Software Validation in ISO 13485:2016

As I am sure many of you know, the ISO 13485 standard was updated in 2016, which means the time to t...
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...
Medical Device QMS Changes: How to Manage Changes Regarding EU MDR, IVDR & ISO 13485:2016 - Featured Image

Medical Device QMS Changes: How to Manage Changes Regarding EU MDR, IVDR & ISO 13485:2016

One thing that seems to be constant in the global medical device industry is change.

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Providing you actionable tips, best practices and insights for better medical device quality, compliance and product development.

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