Quality Assurance Management for Medical Devices (Level 1)

Quality Assurance Management for Medical Devices (Level 1)

QA, medical device, medtech

Limited availability | See below

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What is a Medical Device?
What is a Medical Device?
What actually counts as a medical device? Are there different types of medical devices? How do I begin to know what my regulatory path will be? Get the answers to these questions and more in this course!
0 hr 42 min
EU MDR ISO 13485 Device Classification 510(k) FDA SAMD Ideation & Prototyping Course
An Overview of Risk Management
An Overview of Risk Management
Learn about risk management for medical devices.
0 hr 28 min
Risk Management ISO 14971 Ideation & Prototyping Initial QMS Procedures Product Development QMS Refinement & Regulatory Submissions Product Launch Standard (Free) Course
Audit Basics
Audit Basics
Learn the difference between audits, inspections, and the different types of each you may encounter in the medical device industry.
0 hr 42 min
Audit EU MDR ISO 13485 FDA Initial QMS Procedures QMS Refinement & Regulatory Submissions Product Launch Post-Market Surveillance Course
Documenting Risk Management to Meet Requirements of ISO 14971:2019
Documenting Risk Management to Meet Requirements of ISO 14971:2019
A session by Edwin Bills, Consultant
0 hr 50 min
ISO 14971 Regulatory Management Initial QMS Procedures Product Development QMS Refinement & Regulatory Submissions Product Launch Post-Market Surveillance Standard (Free) Webinar
How to Embrace Risk for Safer Devices
How to Embrace Risk for Safer Devices
Check out one of our favorite podcast episodes from the Global Medical Device Podcast with Tim Moulton, Founder and President at Motim Industries
Risk Management Ideation & Prototyping Product Development QMS Refinement & Regulatory Submissions Standard (Free) Podcast
Essentials for Clinical Evaluation of Medical Devices
Essentials for Clinical Evaluation of Medical Devices
The Globiox team will discuss how the latest updates to EU MDR & IVDR may impact your approach to post-market clinical follow-ups, how to optimally demonstrate equivalency in your report, and how to establish a continuous follow-up process for post-market.
0 hr 53 min
Initial QMS Procedures QMS Refinement & Regulatory Submissions Clinical Standard (Free) Webinar
Europe's First Device Regulations: A Look Into Manufacturers' Response to the Delay, Transition, & Implementation Process
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
What Role Should Quality Play in Bringing a Device to Market?
What Role Should Quality Play in Bringing a Device to Market?
A session by Jon Speer, Founder at Greenlight Guru
0 hr 50 min
Ideation & Prototyping Product Launch Standard (Free) Webinar
How to Maintain a QMS Compliant to MDR & IVDR
How to Maintain a QMS Compliant to MDR & IVDR
Your QMS should be your source of truth, but what happens when the requirements for a QMS change? Get equipped to meet EUMDR and IVDR standards by checking out this talk from Kyle Rose.
0 hr 52 min
Initial QMS Procedures QMS Refinement & Regulatory Submissions Post-Market Surveillance Webinar
Ultimate Guide to 21 CFR Part 820 - FDA's Quality System Regulation for Medical Devices
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..
Risk Management Document Management CAPA Design Controls QMS Initial QMS Procedures Post-Market Surveillance Advance Exclusive eBook
ISO 14971 Risk Management for Medical Devices
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
The Definitive Guide to Change Management for Medical Devices
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
Quality Assurance Management Checkpoint Alpha
Quality Assurance Management Checkpoint Alpha
We are so excited you are on this journey with us! Unlock this course after completing Path 1 from the collection and earn your Specialist Badge.
Advance Exclusive

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