A Complete Guide to Bringing a Medical Device to Market
A complete guide for medical device manufacturers looking for guidance on how to plan for a successful product launch and maintain regulatory compliance across global markets.
Risk Management
Design Controls
QMS
Ideation & Prototyping
Initial QMS Procedures
Product Development
QMS Refinement & Regulatory Submissions
Product Launch
Post-Market Surveillance
Advance Exclusive
eBook
Risk Management Plan Template
Plan your approach to risk within your quality management system with this helpful template to get you started.
Limited Availability
Risk Management
Template
Advance Exclusive
The Art of Defining Design Inputs and Design Outputs
The art of defining design inputs & design outputs for FDA compliance by medical device manufacturers.
Limited Availability
Design Controls
QMS
Product Development
Advance Exclusive
eBook
The Ultimate Guide to CAPA
This guide will provide you with best practices and ways to improve your CAPA process and approach so that you can ultimately ensure the medical devices you design, develop, manufacture, and sell will be as safe and effective as possible for those patients that depend upon them.
Limited Availability
CAPA
QMS
Product Launch
Post-Market Surveillance
Advance Exclusive
eBook
The Ultimate Guide to Training Management for Medical Device Companies
This ultimate guide provides an in-depth look at answers to those common questions and explains everything you need to know to comply with the applicable requirements as well as establish a training management system that promotes total competence of the members of your medical device organization.
Limited Availability
Training
ISO 13485
QMS
Initial QMS Procedures
Post-Market Surveillance
Advance Exclusive
eBook
The Definitive Guide to Responding to FDA 483 and Warning Letters
This guide will go into great detail regarding exactly how to respond to FDA 483 observations and warning letters.
Limited Availability
Initial QMS Procedures
QMS Refinement & Regulatory Submissions
Post-Market Surveillance
Advance Exclusive
eBook
A Complete Guide to 21 CFR Part 11
In this comprehensive guide, we’ll take you through each section of 21 CFR Part 11, explaining what the requirements actually mean and expounding the most important points for you to know as a medical device company.
Initial QMS Procedures
QMS Refinement & Regulatory Submissions
Advance Exclusive
eBook
The Definitive Guide to Change Management for Medical Devices
This guide will detail the change management best practices that medical device companies need to understand and follow when making changes to documents, products, processes, and more.
Limited Availability
Document Management
Change Management
Initial QMS Procedures
Product Launch
Post-Market Surveillance
Advance Exclusive
eBook
Ultimate guide to Agile Design and Development for Medical Devices
In this guide, we discuss how the Agile Method for Medical Device Design is an iterative process that includes all products and product features that are tested, verified and validated, and allows for tweaks, requirement changes, risk updates and compliance updates as needed.
Limited Availability
Risk Management
Document Management
Design Controls
Change Management
Ideation & Prototyping
Product Development
Advance Exclusive
eBook
The Beginners Guide to Design Verification and Design Validation for Medical Devices
In this guide, we’ll go through the basics of design verification, design validation, best practices you should deploy, pitfalls you should avoid, and plans that will make it all come together.
Limited Availability
Design Controls
Product Development
QMS Refinement & Regulatory Submissions
Advance Exclusive
eBook
Managing Changes to Medical Device QMS
This white paper provides an overview into some of the major changes happening right now, and provides some recommendations to consider when managing these changes. It covers changes to ISO 13485:2016, the EU Medical Device Regulation and In Vitro Diagnostic Device Regulation.
EU MDR
IVDR
ISO 13485
Initial QMS Procedures
Post-Market Surveillance
eBook
A Step-By-Step Guide to Determine how your Medical Device will be Classified
In this guide, I will provide you with a step-by-step approach for determining how your medical device will be classified by U.S. FDA, the European Commission, and Health Canada. Getting a basic understanding of regulatory product classification will be invaluable to your efforts to bring new products to market.
Device Classification
Ideation & Prototyping
Initial QMS Procedures
Product Development
QMS Refinement & Regulatory Submissions
Advance Exclusive
eBook
The Ultimate Guide to ISO 13485:2016 Quality Management System for Medical Devices
In this guide you'll learn about ISO 13485 and why Greenlight Guru founder Jon Speer believes that a QMS should be a set of processes that help you to run a better, more efficient business that focuses on true quality and what is best for the patients who will be recipients of your medical devices.
Limited Availability
ISO 13485
QMS
Initial QMS Procedures
Post-Market Surveillance
Advance Exclusive
eBook
The Risk Management + Design Controls Connection: What Device Makers Need to Know
Greenlight Guru found Jon Speer discusses why design controls and risk management should flow and blend together, and it’s important to establish this flow early in product development.
Risk Management
Design Controls
Product Development
Standard (Free)
eBook
A Step-By-Step Guide to Preparing your FDA 510(k) Submission
Get ready to submit your 510(k) with advice from our industry experts
Document Management
Design Controls
Change Management
Device Classification
QMS
510(k)
Product Development
QMS Refinement & Regulatory Submissions
Advance Exclusive
eBook
Ultimate Guide to 21 CFR Part 820 - FDA's Quality System Regulation for Medical Devices
Join Medical Device Guru Taylor Brown for a discussion on the requirements of 21 CFR Part 820 and why it might not be as challenging as it first seems to meet those requirements..
Limited Availability
Risk Management
Document Management
CAPA
Design Controls
QMS
Initial QMS Procedures
Post-Market Surveillance
Advance Exclusive
eBook
The Ultimate Guide to Design Controls for Medical Device Companies
With this guide, Greenlight Guru founder Jon Speer shares valuable insights to explain what Design Controls are, how to address them, and how they benefit your medical device product development efforts.
Limited Availability
Design Controls
ISO 13485
Ideation & Prototyping
Product Development
Advance Exclusive
eBook
The Ultimate Guide to Document Control for Medical Device Companies
This in-depth guide will take a deep dive into the problems that tend to afflict document control activities, provide detailed explanations of the procedures that make your documentation more efficient, and offer proven effective methods for implementing and leveraging a robust document management system that will catapult the success of your organization and medical device.
Limited Availability
Document Management
Change Management
ISO 13485
QMS
Initial QMS Procedures
Post-Market Surveillance
Advance Exclusive
eBook
ISO 14971 Risk Management for Medical Devices
Use this guide to align with the latest version of ISO 14971 and to learn additional tips and insights for medical device risk management.
Risk Management
QMS
ISO 14971
Ideation & Prototyping
Initial QMS Procedures
Product Development
QMS Refinement & Regulatory Submissions
Product Launch
Post-Market Surveillance
eBook
CAPA Report Template for the Medical Device Industry
Use this template to complete your CAPA reports as a part of your QMS
CAPA
Audit
QMS
Template
Product Launch
Post-Market Surveillance
Advance Exclusive
Customer Feedback and Complaint Form Template
Use this template to document customer feedback and complaints in your QMS.
Audit
QMS
Template
Product Launch
Post-Market Surveillance
Advance Exclusive
Nonconformance Report Template
Use this template to document nonconformance in your QMS.
Limited Availability
Audit
QMS
Template
Product Launch
Post-Market Surveillance
Advance Exclusive
Internal Audit Checklist
If you want to put your focus on quality rather than just ensuring that your company checks all the regulatory "boxes", then putting the time into effective internal auditing is essential. Here's a free checklist.
Limited Availability
Audit
ISO 13485
QMS
Template
FDA
Initial QMS Procedures
Product Launch
Post-Market Surveillance
Advance Exclusive
15 Steps to Creating a Risk-Based CAPA Process
This PDF and infographic will have you implementing risk in your CAPA process in no time.
Initial QMS Procedures
QMS Refinement & Regulatory Submissions
Product Launch
Post-Market Surveillance
Advance Exclusive
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Greenlight Guru Academy specializes in providing education and training resources for medical device professionals.