medical_device_top_posts_2019

Thank you for helping make 2019 another big and exciting year for Greenlight Guru!

We had many things to celebrate over this past year...

We launched a second podcast series, MedTech True Quality Stories. The Greenlight Guru team traveled nationwide to host our first industry conference series tour, The Greenlight Guru True Quality Roadshow. Our customers enjoyed multiple product releases of our medical device QMS (MDQMS) software solution, most notably with our new Digital Design Reviews and Change Management capabilities. And we published hundreds of valuable pieces of free content for the medical device community.

Below is our annual list of the most popular resources we published in 2019. Which content was your favorite from 2019? Let us know in the comments section or send us a note!

Enjoy!

 

Top 10 BLOGS of 2019

 

#10: Qualifying Your Suppliers Using a Risk-based Approach

qualifying suppliers using risk

The risk-based approach you use for supplier management should be looked at as a top-down approach to how you do everything within your medical device company. We offer actionable best practices and advice to device makers for mastering this process.

Read the full blog post here →

 

 

#9: 5 Most Common Mistakes Made When Implementing ISO 14971

5 Most Common Mistakes Made When Implementing ISO 14971

ISO 14971 is the medical device industry globally recognized standard for risk management, yet many device makers struggle with implementing risk within their QMS. We've come up with the 5 most common mistakes companies make when it comes to ISO 14971.

Read the full blog post here →

 

 

#8: 2020 Industry benchmark: STate of Medical Device Product Development & Quality Management

State of header

This original research report shares the results of survey responses from over 500 medical device product development and quality professionals across the globe to offer key insights and findings regarding the current state of the medical device industry.

Read the full report here →

 

 

#7: 5 Most Common Problems with your CAPA Process

5 Most Common Problems with your CAPA Process

The corrective and preventive action process is often an area that medical device companies struggle with. We covered five of the most common issues medical device companies have when issuing and managing CAPAs for their medical devices.

Read the full blog post here →

 

 

#6: How to Write Effective SOPs for Medical Devices

how to write SOPs med devices

The standard operating procedures (SOPs) for medical devices help to ensure consistent quality of products, processes and procedures within a company. This article shows device makers how to write these important artifacts effectively.

Read the full blog post here →

 

 

#5: 8 Most Common Mistakes to Avoid with FDA 21 CFR Part 820

8 most common mistakes to avoid with 21 cfr part 820

Medical device companies selling into the US market must be in compliance with FDA 21 CFR Part 820, the quality system regulation for medical devices. In doing so, companies must avoid these 8 most common mistakes along the way.

Read the full blog post here →

 

 

#4: Complete Guide to Bringing a Medical Device to Market

UG bringing a medical device to market

A complete guide for manufacturers seeking guidance on how to plan for and execute a successful commercialization strategy for bringing a medical device to market and maintain regulatory compliance across global markets.

Read the full blog post here →

 

 

#3: The Essential Guide to Preparing your QMS for EU MDR

eu mdr qms

This is the essential guide for medical device companies selling products in Europe that need help with preparing their quality system for transitioning to the new requirements of EU MDR and maintaining compliance once the new regulation goes into effect.

Read the full blog post here →

 

#2: Best Practices for Effective Medical Device Design Reviews

Design Reviews BPLearn our recommended best practices and tips for device makers to better understand and conduct proper design reviews, which will ultimately improve product development and ensure the safety and efficacy of the medical device.

Read the full blog post here →

 

 

#1: Top 50 Medical Device Product Design and Development Companies

top 50 product design & dev companies

To help medical device companies choose the best fit for a product design and development partner, we’ve developed a list of the top 50 firms from around the world that specialize in these services for the medical device industry.

Read the full blog post here →

 


 

Top 5 Webinars of 2019

 

#5: Understanding Post-market Surveillance under EU MDR: Being Proactive, Not Reactive

Kapstone webinar - PMS EU MDRUnderstanding Post-market Surveillance under EU MDR: Being Proactive, Not Reactive presented by Carolyn Guthrie of Kapstone Medical.  

Access the free on-demand webinar here →

 

 

#4: Prepping your QMS for EU MDR

prepping your qms for eu mdr_rook1-1In our free webinar on "Prepping your QMS for EU MDR" presented by Kyle Rose of Rook Quality Systems, participants learned which critical steps are needed to prepare their QMS for the upcoming EU Medical Device Regulations in 2020.

Access the free on-demand webinar here →

 

#3: When Design Input Requirements Go Wrong

When Design Input Requirements Go Wrong-coverGreenlight Guru's very own, Jon Speer presented When Design Input Requirements Go Wrong to webinar participants, in which he covered some of the most common mistakes medical device companies make when defining design requirements and best practices to avoid them.

Access the free on-demand webinar here →

 

#2: EU MDR: How Do I Interpret The New Regulations And What Do I Need To Be Compliant?

eu mdr- rEU MDR affects all device manufacturers doing business in Europe. Brian Hockett of R&Q presented "EU MDR: How Do I Interpret The New Regulations And What Do I Need To Be Compliant?" to industry professionals, offering valuable guidance on the topic.

Access the free on-demand webinar here →

 

#1: An Exclusive Look At The New Changes To ISO 14971:2019 And ISO TR 24971:2019

E.Bills webinar - ISO 14971_2019The most attended webinar in medical device history, "An Exclusive Look At The New Changes To ISO 14971:2019 And ISO TR 24971:2019", presented by Edwin Bills, an author of the latest version of the standard, gave viewers an inside look at the important changes to the industry standard for risk management.

Access the free on-demand webinar here →


 

TOP 5 Podcasts OF 2019

 

#5: Why Design Verification Matters

Design verification can be a difficult stage for medical device companies to carry out effectively. Mike Drues joins Jon Speer to discuss the nuances of design verification as it relates to quality and design controls of medical device development.

Listen to the full episode here →

 

 

#4: EU MDR: Not All Doom and Gloom

podcast_rebecca sheridan

When it comes to EU MDR, a majority of device makers have felt some level of doom, gloom, concern, or fear. Episode guest and former regulator herself, Rebecca Sheridan joins the show to share some positive insights and updates regarding EU MDR and IVDR.

Listen to the full episode here →

 

 

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

podcast_larry-mager

This episode features guest Larry Mager, who describes the difference between quality management system (QMS) and quality systems management (QSM), and offers tips to help device businesses become more efficient in order to benefit patients.

Listen to the full episode here →

 

 

#2: Medical Device Product Development Value Proposition

podcast_scott-phillips

It's critical for both startups and established companies to remain focused on the value proposition of its device product development efforts. Scott Phillips joins the show to offer advice on how to approach value proposition based on the stage of your business.

Listen to the full episode here →

 

 

#1: Grasping The Impact of Artificial Intelligence And Machine Learning on Medical Devices

FDA recently issued a statement about the potential impact of artificial intelligence (AI) and machine learning (ML) in healthcare. Mike Drues and Jon Speer discuss nuances, regulations, and implications to consider with AI and ML medical devices and software.

Listen to the full episode here →

 


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