From Concept to Commercialization: Introduction to Medical Device Development
So you have an idea for a medical device...what now? This course gives a quick overview of the process of developing a medical device and offers a few practical examples from our experiences in the industry.
0 hr 32 min
EU MDR
QMS
FDA
Ideation & Prototyping
Initial QMS Procedures
Product Development
QMS Refinement & Regulatory Submissions
Product Launch
Post-Market Surveillance
Course
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
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
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
Essentials of Software as a Medical Device
With software being a growing industry, in general, it is no surprise that this popularity is making its way to medical devices. This course will give a quick overview of what we mean by Software as a Medical Device as well as what the regulations say about it and how it differs from other medical device development.
0 hr 42 min
SAMD
Initial QMS Procedures
Product Development
QMS Refinement & Regulatory Submissions
Software
Cybersecurity
Course
Standards and Pathways to the USA Medical Device Market
Anyone looking to launch a medical device into the United States market should be familiar with the FDA and the regulations they use. This course will give you a look at the regulations themselves and a little history on the FDA and how it came to be.
0 hr 42 min
Device Classification
QMS
510(k)
FDA
Initial QMS Procedures
Product Development
QMS Refinement & Regulatory Submissions
Course
How to Implement Risk Management into Regulatory Submissions Using Tips, Tricks, and Standards to Satisfy FDA Concerns
A session by Mary McNamara-Cullinane. Senior Vice President of Regulatory Affairs, Alira Health.
0 hr 47 min
Product Development
QMS Refinement & Regulatory Submissions
Standard (Free)
Webinar
