Challenges with Applying Risk Management Throughout the Manufacturing Process
Every medical device developer has to understand risk management. You could learn the hard way, or you could listen to our experts share their trials and successes on this important topic.
Risk Management
ISO 14971
manufacturing
Product Development
Product Launch
Post-Market Surveillance
Advance Exclusive
Podcast
Change Management and Risk Management: How do we connect the dots and what happens if we don't?
Change management and risk management should work together, but it does take some work to make that happen. Let us help with these important tips and sage advice from Mike Drues.
Risk Management
Change Management
Initial QMS Procedures
Product Development
Product Launch
Post-Market Surveillance
Advance Exclusive
Webinar
Protecting your Data from Risk: To, From, and In the Cloud
A session by Chris DuPont, CEO at Galen Data
0 hr 45 min
Ideation & Prototyping
Product Development
QMS Refinement & Regulatory Submissions
Product Launch
Post-Market Surveillance
Advance Exclusive
Webinar
Overview of Nonconformance
This course will help you understand what nonconformance means in the medical device industry, what is required by regulating bodies, and how a well managed nonconformance process will help you make safer and more effective devices.
0 hr 17 min
Nonconformance
Initial QMS Procedures
QMS Refinement & Regulatory Submissions
Product Launch
Post-Market Surveillance
Advance Exclusive
Course
How to Prepare for Common MDR Audit Pitfalls
A session by Bassil Akra, CEO and Co-Owner, QUNIQUE GmbH
0 hr 53 min
Initial QMS Procedures
QMS Refinement & Regulatory Submissions
Product Launch
Post-Market Surveillance
Standard (Free)
Webinar
Implementing and Maintaining Changes to SaMD Under MDR
This session will cover the outline of MDR requirements for SaMD, including qualification and classification, clinical evaluation and expanded post-market activities among others.
0 hr 51 min
Product Development
QMS Refinement & Regulatory Submissions
Advance Exclusive
Webinar
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.
Document Management
Change Management
ISO 13485
QMS
Initial QMS Procedures
Post-Market Surveillance
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.
ISO 13485
QMS
Initial QMS Procedures
Post-Market Surveillance
Advance Exclusive
eBook
