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Biocompatibility Nuances and its Impact on Medical Devices - Featured Image

Biocompatibility Nuances and its Impact on Medical Devices

Biocompatibility can be challenging and frustrating when developing a medical device. Why do you hav...
ISO 13485 Medical Device Quality System Standard and Other Regulatory Conundrums - Featured Image

ISO 13485 Medical Device Quality System Standard and Other Regulatory Conundrums

The 2003 edition of ISO 13485 has now been withdrawn and fully replaced by the 2016 edition.[i]  As ...
Case Study: How Innovere Accelerated Their Path To Market By Implementing Greenlight Guru’s Medical Device eQMS - Featured Image

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

    Advanced magnetic resonance imaging (MRI) technology has become an important piece of healthcare...
Why Document Control Matters To Medical Device Companies - Featured Image

Why Document Control Matters To Medical Device Companies

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 - Featured Image

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

In a world of rapidly changing regulatory requirements, achieving new certifications, such as ISO 13...
Case Study: How Greenlight Guru is Laying the Foundation for Success at Amnion Life - Featured Image

Case Study: How Greenlight Guru is Laying the Foundation for Success at Amnion Life

The majority of medical device companies operate on an emphasis of high quality outcomes and scalabi...
Quality Systems Management (QSM) vs. Quality Management System (QMS) - What's The Difference? - Featured Image

Quality Systems Management (QSM) vs. Quality Management System (QMS) - What's The Difference?

Do you know the difference between quality management system (QMS) and quality systems management (Q...
Proactive Quality Systems: FDA Is Prioritizing Them...And You Should Too - Featured Image

Proactive Quality Systems: FDA Is Prioritizing Them...And You Should Too

FDA’s traditional compliance requirements establish a uniform quality system framework, but do not e...
Why Contract Manufacturers Shouldn't Own Your Quality System - Featured Image

Why Contract Manufacturers Shouldn't Own Your Quality System

Does your medical device company use a third-party or contract manufacturer?
FDA Case for Quality: 2018 Comprehensive Review - Featured Image

FDA Case for Quality: 2018 Comprehensive Review

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...
Ultimate Guide to ISO 13485 Quality Management System (QMS) for Medical Devices - Featured Image

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

            TABLE OF CONTENTS What is ISO 13485 Evolution of a Quality Management System ISO 13485 C...

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