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
CE Mark Technical Documentation: Changes, Application, and Notified Body Expectations under MDR
This presentation will provide an overview of the technical documentation requirements under MDR including format and content.
0 hr 54 min
Initial QMS Procedures
Product Development
QMS Refinement & Regulatory Submissions
Advance Exclusive
Webinar
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
Europe's First Device Regulations: A Look Into Manufacturers' Response to the Delay, Transition, & Implementation Process
Jon Speer, Founder of Greenlight Guru, will dive into key data and findings from Greenlight Guru's upcoming EU MDR Report, which surveyed hundreds of medical device professionals from all over the world.
0 hr 57 min
QMS Refinement & Regulatory Submissions
Product Launch
Post-Market Surveillance
Standard (Free)
Webinar
Evaluating need for Biocompatibility Testing & Mitigating Risks when Changing your Medical Device
When you want to know more about biocompatibility, you go to the experts! Hear Thor Rollins of Nelson Labs discuss this crucial topic about the intersection of risk, biocompatibility, and change management.
Risk Management
Change Management
Initial QMS Procedures
Product Development
QMS Refinement & Regulatory Submissions
Advance Exclusive
Webinar
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.
Document Management
Change Management
Initial QMS Procedures
Product Launch
Post-Market Surveillance
Advance Exclusive
eBook
