Quality Assurance Management for Medical Devices (Level 2)

Quality Assurance Management for Medical Devices (Level 2)

QA, medical device, medtech

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Who Owns Risk Management and How Does it Impact the Business?
Who Owns Risk Management and How Does it Impact the Business?
A session by Jon Speer, Founder at Greenlight Guru
1 hr 1 min
Ideation & Prototyping Product Development Function Webinar

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15 Steps to Creating a Risk-Based CAPA Process
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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3 Keys to Successful Internal Audits
3 Keys to Successful Internal Audits
Gurus Taylor Brown and Sara Adams discuss their top 3 ways to have better internal audits in this quick video
0 hr 4 min
Audit Initial QMS Procedures QMS Refinement & Regulatory Submissions Product Launch Post-Market Surveillance Advance Exclusive Webinar

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3 Systems of Risk for Medical Devices
3 Systems of Risk for Medical Devices
Learn about the 3 systems of risk the FDA may use when evaluating your device submission and how you can manage each one.
Risk Management Ideation & Prototyping Initial QMS Procedures Product Development QMS Refinement & Regulatory Submissions Advance Exclusive Podcast

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A Complete Guide to 21 CFR Part 11
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

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Overview of CAPA
Overview of CAPA
The CAPA process is almost always a topic of audits and inspections and regularly one of the top reasons for medical device submissions to be rejected by regulatory bodies. Learn what this process is and why it's so important to creating safer and better medical devices.
0 hr 17 min
CAPA Initial QMS Procedures QMS Refinement & Regulatory Submissions Product Launch Post-Market Surveillance Advance Exclusive Course

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Managing Changes to Medical Device QMS
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

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How to Meet Cybersecurity Requirements of EU MDR & IVDR
How to Meet Cybersecurity Requirements of EU MDR & IVDR
EU MDR and IVDR are changing and cybersecurity requirements are no exception. Get the details in this important discussion with Justin from TUV SUD.
0 hr 54 min
Initial QMS Procedures Product Development QMS Refinement & Regulatory Submissions Advance Exclusive Webinar

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Risk Management from a Regulatory and Product Development Perspective
Risk Management from a Regulatory and Product Development Perspective
Another favorite podcast episode with our frequent guest Mike Drues, Ph.D.
Risk Management Regulatory Management Product Development QMS Refinement & Regulatory Submissions Advance Exclusive Podcast

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Risk Management for Executives: Why Does it Matter to Me?
Risk Management for Executives: Why Does it Matter to Me?
A session by Michael Cremeans, Life Sciences Industry Practice Leader at Hylant
0 hr 44 min
Webinar

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The Who, What, and When of IVDR Enforcement
The Who, What, and When of IVDR Enforcement
A session by Joanne Lebrun, Vice President at MDC Associates Inc.
0 hr 52 min
EU MDR Post-Market Surveillance Advance Exclusive Webinar

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The Ultimate Guide to CAPA
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.
CAPA QMS Product Launch Post-Market Surveillance Advance Exclusive eBook

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Quality Assurance Management Checkpoint Beta
Quality Assurance Management Checkpoint Beta
You're graduating to the level of "Authority". You know your stuff and it's time you got a shiny new badge to prove it. Check-in here and you'll be ready to move on to level 3!
Advance Exclusive

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