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

C2DX, Inc. Impresses Auditors and Achieves MDSAP Certification After Implementing Medical Device QMS (MDQMS)

By Nick Tippmann on October 17, 2019

Experienced medical device professionals can agree that investing in quality early on and putting ...

5 Do's and Don'ts when Choosing a QMS Solution for your Medical Device Company

By Jon Speer on October 6, 2019

As a medical device manufacturer, your quality management system is the heart of your operations.

Best Practices for Expediting Your Product Development

By Jon Speer on September 15, 2019

Speed to market is one of the major challenges for medical device companies. So, how can you expedit...

5 Tips from MedTech Executives on the Value of Quality

By Jon Speer on September 8, 2019

When it comes to making medical devices, quality is key.

Photonicare Adopts Medical Device QMS Software to Accelerate Time to Market

By Nick Tippmann on August 19, 2019

Ultimate Guide to Agile Design and Development for Medical Devices

By Agile Medical Device Design (AMDD) on August 4, 2019

Table of Contents Overview - Agile Design and Development for Medi...

Case Study: Centese ditches paper-based QMS AND achieves FDA 510(k) clearance

By Nick Tippmann on March 29, 2019

For many early-stage medical device companies, the default option when implementing a quality manage...

Case Study: How Innovere Accelerated Their Path To Market By Implementing Greenlight Guru’s Medical Device eQMS

By Nick Tippmann on March 28, 2019

Advanced magnetic resonance imaging (MRI) technology has become an important piece of healthcare...

Why Document Control Matters To Medical Device Companies

By Jon Speer on March 24, 2019

As medical device professionals, we share a common goal of producing safe and effective medical devi...

Lucerno Dynamics Has Simplified the ISO 13485:2016 Certification Process With Greenlight Guru

By Nick Tippmann on March 13, 2019

In a world of rapidly changing regulatory requirements, achieving new certifications, such as ISO 13...

Case Study: How AMNION LIFE IS LAYING THE FOUNDATION FOR SUCCESS WITH GREENLIGHT GURU

By Nick Tippmann on March 12, 2019

The majority of medical device companies operate on an emphasis of high quality outcomes and scalabi...

Quality, Fast, Cheap...Pick Two

By Mark D Proulx, CQA, cSSBB on February 24, 2019

You may think you're saving the company money by using that "free" Excel spreadsheet to track design...

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