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Webinar

Maximizing Clinician Participation in Post-Market Operations

Live demo addressing key challenges faced by clinicians and distributors in obtaining post-market surveillance feedbac, and exploring best practices for successful clinician ...

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Thought Leadership Article

Fifteen Questions to Ask QMS Software Vendors in the Medical Device Industry

By Etienne Nichols, Quality Digest

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Webinar

Alternatives to PMCF Clinical Investigations

In this webinar, leading MedTech experts from QServe and SMART-TRIAL by Greenlight Guru share their insights on alternatives to PMCF clinical investigations and suggest ways ...

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eBook

Ultimate Guide to Postmarket Surveillance of Medical Devices

This eBook of the Ultimate Guide to Postmarket Surveillance covers the regulations that manufacturers must follow, along with best practices and tips for carrying out PMS ...

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Webinar

How to Collect PMCF Data for Lower Class Devices and WETs

In this free webinar, SMART-TRIAL‘s PMCF expert, Jón Bergsteinsson, teams up with CEO of Evnia, Efstathios Vassiliadis, to present you with a simple, yet powerful tool, to collect ...

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Case Study

Monitored Therapeutics, Inc: Building an Audit-ready QMS in 3 Months

“Purchasing Greenlight Guru was the best decision for our needs. Their easy-to-use eQMS, SOP Templates, and expert Guru guidance were key to us being able to successfully navigate ...

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Checklists and Templates

Medical Device Reporting (MDR) Decision Tree

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Thought Leadership Article

Three Things MedTech Firms Need to Do for 'True Quality'

By Nick Tippmann, Medical Product Outsourcing

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Thought Leadership Article

Top Hiring and Recruiting Tips for Med-Tech Companies

By Nick Tippmann, Medical Product Outsourcing

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Thought Leadership Article

True Quality Experts Weigh in on MedTech Future Trends

By Nick Tippmann, Medical Product Outsourcing

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Thought Leadership Article

Finding from Greenlight Guru's Benchmark Survey of 519 Medtech Professionals

By Etienne Nichols, Project Medtech Podcast

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Thought Leadership Article

Supplier Quality Management: What MedTech Manufacturers Need to Know

By Nick Tippmann, Med-Tech Innovation

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Thought Leadership Article

Three Lessons from True Quality 2022

By Nick Tippmann, 24x7 Magazine

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eBook

Selecting the Ideal PMCF Activity

Ultimate guide supplying medical device manufacturers with an overview of both generic and specific PMCF activities, and guidance on when and how to include them in your PMCF plan.

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Thought Leadership Article

Three Things You Need to Know About FDA QSR and ISO 13485 Harmonization

By Etienne Nichols, MedTech Intelligence

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Global Medical Device Podcast

Tips For Being Prepared Post-EUA (Emergency Use Authorization)

Episode 242

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Thought Leadership Article

The End of EUA Is Coming Soon

By Jon Speer, Medical Product Outsourcing

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Thought Leadership Article

4 Red Flags Investors Look For When Vetting Your Medical Device Company

By Nick Tippmann, MedTech Intelligence

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Thought Leadership Article

Risk Management for Medical Devices

By Wade Schroeder, Quality Digest

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Global Medical Device Podcast

What Are The Top Compliance Issues Plaguing Medical Device Manufacturers?

Episode 235

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Thought Leadership Article

EU MDR Preparedness: How Is COVID-19 a Factor?

By Jon Speer, Medical Product Outsourcing

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Thought Leadership Article

How a Medical Device QMS Can Lead to More Efficient and Sustainable Diagnostic Tests

By Brandon Henning, Medical Product Outsourcing

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Thought Leadership Article

Closed-Loop Traceability for FDA Compliance

By Jon Speer, Quality Digest

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Thought Leadership Article

Preparing for the EU’s MDR

By Nick Tippmann, Medical Product Outsourcing

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Thought Leadership Article

What Are the Biggest Changes under EU MDR?

By Jon Speer, MedTech Intelligence

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Thought Leadership Article

Using Quality as an Advantage in 2021

By Jon Speer, Medical Product Outsourcing

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Thought Leadership Article

Three Reasons Automation and Training Are Essential in Your Medical Device QMS

By Jon Speer, Medical Product Outsourcing

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Thought Leadership Article

What Is Quality Culture and Does Your Company Have It?

By Jon Speer, Medical Device and Diagnostic Industry

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Thought Leadership Article

Why You Must Have a Single Source of Truth for CAPA

By Jon Speer, MedTech Intelligence

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Global Medical Device Podcast

Virtual Auditing in a Post-COVID World of Digital Compliance

Episode 180

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Checklists and Templates

Change Impact Analysis Template

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Checklists and Templates

Change Order Template

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Global Medical Device Podcast

Post-Pandemic Readiness: Preparing for the Aftermath of COVID-19 on the Medical Device Industry

Episode 173

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Checklists and Templates

Nonconformance Report Template

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Thought Leadership Article

Expert Roundup: Achieving Success in the 2021 Medical Device Landscape

By Nick Tippmann, Medical Product Outsourcing

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Thought Leadership Article

Imagine It’s 2030: What Was the Key To Business Success During COVID-19?

By David DeRam, Inside INdiana Business

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Thought Leadership Article

Traceability Requirements in EU MDR

By Jon Speer, Medical Device and Diagnostic Industry (MD+DI)

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Thought Leadership Article

Four Essential Processes in Medical Device Risk Management

By Jon Speer, Quality Digest

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Checklists and Templates

Complaint Template

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Checklists and Templates

CAPA Template

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Thought Leadership Article

Adopting a Data-Driven Approach to Quality with a Medical Device QMS

By Jon Speer, Medical Product Outsourcing

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Checklists and Templates

7 Steps for Writing a Nonconformance Report

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Thought Leadership Article

The Importance of Managing and Controlling Risk in the Medical Device Industry

By Jon Speer, Quality Digest

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Thought Leadership Article

Why I Left a MedTech Manufacturer For a Software Scale-Up

By Wade Schroeder, Inside INdiana Business

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Webinar

How to Implement and Maintain a Modern CAPA System while Avoiding Common Pitfalls

A free, in-depth webinar covering proven methods to improve your CAPA processes and tactical approaches you can start taking today to ensure the medical devices you design, ...

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Thought Leadership Article

Areas to Consider in Medical Device Risk Management

By Jon Speer, Medical Product Outsourcing

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Thought Leadership Article

Ensure Success Throughout the Entire Medical Device Lifecycle

By Jon Speer, Medical Device and Diagnostics Industry

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Thought Leadership Article

What Consumer Tech Companies Need To Know About Medical Devices In The European Union

By David DeRam, Forbes

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Thought Leadership Article

From the Experts: Best Practices to Ensure Device Success

By Jon Speer, Medical Product Outsourcing

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Thought Leadership Article

Best Practices for Leading Medical Device Teams During the COVID-19 Pandemic

By Jon Speer, MedTech Intelligence

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Thought Leadership Article

Managing and Leading Medical Device Companies and Teams During the Pandemic

By Jon Speer, Medical Product Outsourcing

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Thought Leadership Article

COVID-19’s Impact on the MedTech Industry: How to Get Through

By Jon Speer, MedTech Intelligence

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Thought Leadership Article

What You Need to Know for an Effective Risk Assessment

By Jon Speer, Quality Digest

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Thought Leadership Article

What Consumer Tech Companies Need To Know About Medical Devices In The US

By David DeRam, Forbes

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Thought Leadership Article

Engineers: How to Curb Quality Myths Now

By Jon Speer, MedTech Intelligence

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Thought Leadership Article

Building a Medtech Firm on a Foundation of Quality

By Nick Tippmann, Medical Product Outsourcing

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Thought Leadership Article

Paper Processes: Three Reasons It’s a Costly Business Move

By Jon Speer, MedTech Intelligence

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Thought Leadership Article

Paper Is Expensive

By Jon Speer, Quality Digest

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Thought Leadership Article

The True Cost of Paper

By Jon Speer, Medical Product Outsourcing

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Thought Leadership Article

4 Powerful Ways Mindfulness Encourages Peak Performance

By David DeRam, Forbes

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Thought Leadership Article

Why Great Companies Don't Run On Spreadsheets

By David DeRam, Forbes

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Thought Leadership Article

3 Keys to Attracting Investors and Raising Funds for Your Med Device

By Jon Speer, Healthcare Business Today

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Thought Leadership Article

Six Mistakes to Avoid When Implementing ISO 13485

By Jon Speer, Medical Product Outsourcing

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Thought Leadership Article

5 Tips To Raise Funding For Your Medical Device

By Jon Speer, Medical Design & Outsourcing

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Thought Leadership Article

5 Tips to Raise Investor Interest and Fund Your Medical Device

By Jon Speer, Medical Product Outsourcing

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Thought Leadership Article

4 Keys to Funding Your Medical Device

By Jon Speer, MedTech Intelligence

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Global Medical Device Podcast

Navigating the Twists and Turns of Change Management for Medical Devices

Episode 130

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Webinar

Implementing Best Practice Medical Device Change Control Processes (While Avoiding Common Pitfalls)

A free webinar on how you can establish an effective medical device change control process to ensure internal consistency throughout your quality management systems and ...

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Thought Leadership Article

We’re going through changes: Major upcoming regulatory changes for manufacturers explained

By Jon Speer, Medical Plastics News

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eBook

Definitive Guide to Change Management for Medical Devices

A definitive guide on change management best practices to help medical device companies understand and manage changes to documents, products, processes and more.

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Thought Leadership Article

Top 3 Mistakes You Can Make When Adopting ISO 13485

By Jon Speer, Medtech Intelligence

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Thought Leadership Article

A Tsunami of Regulatory Changes is Coming

By Jon Speer, InCompliance

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Thought Leadership Article

Top 4 Mistakes When Implementing ISO 13485

By Jon Speer, Medical Design & Outsourcing

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Thought Leadership Article

Five Tips From Medtech Executives on the Value of Quality

By Jon Speer, Quality Digest

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Webinar

Post-market Surveillance For Medical Devices And Combination Products: If A Device Is Fda Cleared Or Approved, Can We Assume It’s Safe And Effective?

In this free webinar participants will learn post-market surveillance best practices for medical devices and combination products to avoid timely and costly mistakes, as ...

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Thought Leadership Article

The Essential Guide To Preparing Your QMS For EU MDR

By Jon Speer, The MedTech Conference

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Glossary

Root Cause Analysis

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Thought Leadership Article

Not All Medical Device QMS Solutions Are Created Equal

By Evan Luxon, Centese (Greenlight Guru customer), Medical Product Outsourcing

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Thought Leadership Article

Quality Is The Heartbeat Of Your Company

By David Deram, Forbes

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Thought Leadership Article

Qualifying Your Suppliers Using a Risk-Based Approach

By Jon Speer, Quality Digest

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Global Medical Device Podcast

Is Your Medical Device Company CAPA Happy?

Episode 106

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Glossary

Customer Complaint Handling Process

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Thought Leadership Article

Choosing The Right QMS For Your Medical Device Company

By Evan Luxon, Centese (Greenlight Guru customer), MedTech Intelligence

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Thought Leadership Article

The Most Common Problems With Your CAPA Process

By Jon Speer, ECN

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Webinar

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

A free webinar on the newly codified regulatory requirements for post-market surveillance (PMS) under the new Medical Device Regulations (MDR) that goes into effect May 2020, ...

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Thought Leadership Article

What To Expect During an FDA QSIT Inspection

By Jon Speer, Quality Digest

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Thought Leadership Article

Top 26 Medical Device Conferences To Attend in 2019

By Jon Speer, ECN Magazine

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Thought Leadership Article

Creating an It Factor Culture

By David Deram, The Sales Evangelist

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Thought Leadership Article

2019 MedTech Predictions

By Jon Speer, MedTech Intelligence

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Glossary

MEDDEV Vigilance

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Thought Leadership Article

6 Best Practices for Complying with ISO 13485:2016

By Jon Speer, Medical Product Outsourcing

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Checklists and Templates

Most Common Sources of Post-market Surveillance Data

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Checklists and Templates

15 Steps to Create a Risk-based CAPA Process Infographic

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Checklists and Templates

4 Steps to Gathering Accurate Complaint Data

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Checklists and Templates

Overview of a Customer Complaint-handling Procedure

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Checklists and Templates

Guide to When to Use Different Tools for CAPA Analysis

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Checklists and Templates

FDA 483 & Warning Letter Checklist

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Checklists and Templates

4 Signs You Need to Issue a CAPA

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Checklists and Templates

4 Reasons the Root Cause Isn't "User Error" Cheatsheet

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Checklists and Templates

What FDA Expects to See as Part of Your CAPA Process Cheatsheet

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Checklists and Templates

5 Step Checklist to Determine If a CAPA Is Required

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Checklists and Templates

4 Methods for Root Cause Analysis Cheat Sheet

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Checklists and Templates

5 "Whys" for Root Cause Analysis Technique Cheat Sheet

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Checklists and Templates

8 Quick Facts about CAPA Cheat Sheet

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Glossary

Corrective Action Plan

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Thought Leadership Article

Why Paper-Based Systems No Longer Make the Cut

By David DeRam, MedTech Intelligence

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Thought Leadership Article

5 Tips for Post-Market Medical Device Compliance

By Jon Speer, Medical Design & Outsourcing

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Thought Leadership Article

Why Cloud Software Companies Should Build for Vertical Industries

By David DeRam, DZone

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Thought Leadership Article

5 Reasons Design Controls and Risk Management Processes Fail

By Jon Speer, Medical Product Outsourcing

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Thought Leadership Article

Cloud Companies Should Build for Vertical Industries

By David DeRam, InformationWeek

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Thought Leadership Article

How to Avoid a Medtech Document Scavenger Hunt

By Jon Speer, MedCity News

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Glossary

CORRECTIVE ACTION VS PREVENTIVE ACTION

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Glossary

CORRECTIVE AND PREVENTIVE ACTION FORM

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Glossary

CORRECTIVE AND PREVENTIVE ACTION REPORT

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Glossary

NONCONFORMANCE MANAGEMENT

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Glossary

CORRECTIVE ACTION PROCEDURE

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Glossary

POSTMARKET SURVEILLANCE

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Thought Leadership Article

Five Common Mistakes Companies Make With CAPA

By Jon Speer, Quality Digest

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Thought Leadership Article

Why the FDA Presubmission Is an Underutilized Tool

By Jon Speer, Quality Digest

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Thought Leadership Article

A timeline to adopt medical device QMS (and why you need to act now)

By Jon Speer, MedCity News

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Thought Leadership Article

How To Structure Your Internal Audit Program

By Jon Speer, Med Device Online

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Thought Leadership Article

Here’s what you need to know about FDA’s new guidance on software as a medical device

By Jon Speer, MedCity News

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Thought Leadership Article

Elite Sports Teams Are Much Better at Creating Powerful Cultures Than Startups — Here Are 5 Tips You Can Steal

By David DeRam, Business 2 Community

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Thought Leadership Article

How to streamline the customer complaint handling process

By Jon Speer, Medical Design & Outsourcing

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Thought Leadership Article

The Impact of Risk Management on CAPA

By Jon Speer, Medical Device and Diagnostics Industry

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Thought Leadership Article

The Countdown to Implementing ISO 13485:2016

By Jon Speer, Medical Device and Diagnostics Industry

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Thought Leadership Article

Greenlight Guru Revenue Rockets In Q4, Plans Hiring Spree In Q1

By Greenlight Guru, Med Device Online

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Thought Leadership Article

How to Integrate Complaint Handling and Risk Management

By Jon Speer, Quality Digest

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Thought Leadership Article

5 things to address if you’re a medical device startup

By Jon Speer, Med-Tech Inovation

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Thought Leadership Article

What should really trigger a CAPA?

By Jon Speer, Medical Design & Outsourcing

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Thought Leadership Article

Why the best engineers are attracted to big problems

By David Odmark, Techpoint

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Thought Leadership Article

5 predictions for the medical device industry in 2018 (and how you can prepare)

By Jon Speer, MedCity News

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Thought Leadership Article

The potential impact of FDA’s use of PRO to assess effects of medical devices

By Jon Speer, MedCity News

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Thought Leadership Article

How CAPA Connects to Other QMS Processes

By Jon Speer, Quality Digest

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Thought Leadership Article

What a Risk-Based QMS Means

By Jon Speer, Quality Digest

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Thought Leadership Article

5 Tips for Medical Device Engineers on FDA Design Controls

By Jon Speer, Diagnostic and Interventional Cardiology

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Thought Leadership Article

The 5 Most Common Problems With Your CAPA Process

By Jon Speer, Med Device Online

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Thought Leadership Article

Design History File vs. 510(k) vs. Technical File: What Do Medical Device Developers Need to Know?

By Jon Speer, Medical Device and Diagnostics Industry

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Thought Leadership Article

Design Validation vs. Clinical Evaluation: What's the difference?

By Jon Speer, Quality Digest

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Thought Leadership Article

How to prepare your medical device company for an FDA inspection

By Jon Speer, MedCity News

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Thought Leadership Article

How to define and decode your design inputs and design outputs

By Jon Speer, Mass Device

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Thought Leadership Article

How to define and decode your design inputs and design outputs

By Jon Speer, Medical Design & Outsourcing

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Thought Leadership Article

7 Common Mistakes That Sink FDA 510(k) Clearance

By Jon Speer, Med Device Online

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Thought Leadership Article

Elite Sports Teams Are Much Better at Creating Powerful Cultures Than Startups -- Here Are 5 Tips You Can Steal

By David DeRam, Entrepreneur

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Thought Leadership Article

How to Debunk the Most Common CAPA Myths

By Jon Speer, The MedTech Conference

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Thought Leadership Article

Proper Design Controls Could Save You $20 Million

By Jon Speer, Medical Product Outsourcing

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Thought Leadership Article

Why Your Medical Device QMS Should Match the Size of Your Company

By Jon Speer, Quality Digest

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Thought Leadership Article

15 Startup Secrets You Can Steal From Sports Cultures

By David DeRam, Powderkeg

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Thought Leadership Article

How to Prepare Your Design History File For An FDA Inspection

By Jon Speer, Med Device Online

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Thought Leadership Article

Debunking 8 commonly held CAPA myths

By Jon Speer, MedCity News

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Thought Leadership Article

Medical device product development: pitfalls you need to avoid

By John Speer, MassDevice

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Thought Leadership Article

Medical device product development: 7 pitfalls you need to avoid

By Jon Speer, Medical Design & Outsourcing

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Thought Leadership Article

Four Ways to Build an Elite Team (On or Off The Field)

By David DeRam, Inside INdiana Business

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Thought Leadership Article

What are the best ways to handle medical device customer complaints?

By Jon Speer, MedCity News

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Thought Leadership Article

What should trigger a CAPA in medical device manufacturing?

By Jon Speer, MedCity News

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Thought Leadership Article

Correcting misconceptions about FDA design controls for the medical device industry

By Jon Speer, MedCity News

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Glossary

Corrective and Preventive Action (CAPA)

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Global Medical Device Podcast

5 Most Common Problems with Your CAPA System

Epsidoe 59

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