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The Power of 3D-Printed Medical Devices
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The "New" Safety & Performance-Based 510(k)
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15 Steps to Creating a Risk-Based CAPA Process
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3 Keys to Successful Internal Audits
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3 Systems of Risk for Medical Devices
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A Complete Guide to 21 CFR Part 11
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A Complete Guide to Bringing a Medical Device to Market
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A Step-By-Step Guide to Determine how your Medical Device will be Classified
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A Step-By-Step Guide to Preparing your FDA 510(k) Submission
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Addressing the Notified Body Bottleneck
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An Overview of Biocompatibility for Medical Devices
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An Overview of Human Factors Engineering for MedTech
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An Overview of UDI Requirements for MedTech
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Applying a Risk-Based Approach to Biological Evaluation of Medical Devices Based on the Framework of ISO 10993-1:2018
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Audit Basics
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Basil Akra: Status of EU MDR and EU IVDR
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Behind the Research: Overcoming the Barriers to Improved Quality
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Biocompatibility Evaluation for Device Submission
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Breakout Session: Best Quality Practices for SaMD, Including AI and ML
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Breakout Session: Communicating with the FDA
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Breakout Session: Incorporating Risk Management throughout your Device Lifecycles
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Building a Regulatory Strategy
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Building Companies and Careers: Your Brand
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Building the Business Case
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By Design: Reduce Risk and Improve Compliance with a Layered Software Architecture
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CAPA Report Template for the Medical Device Industry
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CE Mark Technical Documentation: Changes, Application, and Notified Body Expectations under MDR
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CEO Roundtable: Leading Your MedTech Company in 2023 and Beyond
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Challenges with Applying Risk Management Throughout the Manufacturing Process
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Change Management and Risk Management: How do we connect the dots and what happens if we don't?
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Concept to Commercialization Panel
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Customer Feedback and Complaint Form Template
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Design Controls, Development, and Risk for SaMD
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Developing a New Clinically Relevant ICU Ventilator Fast
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Economic Operators: Implementation Challenges and Opportunities
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Effective Post-market Surveillance in the EU under MDR
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Essentials of Software as a Medical Device
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EU MDR 2017 745 Practitioner Training
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Evaluating need for Biocompatibility Testing & Mitigating Risks when Changing your Medical Device
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FDA 510(k) Overview
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Fireside Chat with a MedTech Living Legend
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From Concept to Commercialization: Introduction to Medical Device Development
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From Self-Declaration to Certification: Proving Performance Under IVDR
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Future of Quality Panel
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How and When to Conduct your First Hazard Analysis
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How to Apply Risk Management Throughout the Product Lifecycle of your Medical Device
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How to Create Medical Device Labels per EU MDR
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How to Efficiently Document your Design Transfer to Ace your Audit and Product Launch
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How to Integrate Risk Management Throughout the Lifecycle of a Medical Device
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How to Meet Cybersecurity Requirements of EU MDR & IVDR
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How to Predict Medical Device Recalls using Publicly Available Data
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Implementation of Risk Management Board for New Product Introduction and PMS
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Implementation of the Risk Management Board for New Product Introduction and Post Market Surveillance
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Implementing and Maintaining Changes to SaMD Under MDR
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Internal Audit Checklist
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Is your Use-Related Risk Analysis Half Empty or Half Full?
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Managing Risks Along an IVD-Analyzer's Life-Cycle
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MedTech Cybersecurity Panel
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Mindset Tools for High Performance Teams
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Nonconformance Report Template
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Overview of CAPA
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Overview of Complaints
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Overview of Nonconformance
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Perfecting the Pitch: Fundraising Roundtable of Early Stage Investors
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Planning your Cloud Connectivity Strategy to Reduce Cybersecurity and Privacy Risk
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Pre-Market vs. Post Market Risk: What are the similarities and differences?
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Product Development and Engineering Checkpoint Alpha
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Product Development and Engineering Checkpoint Beta
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Product Development and Engineering Checkpoint Charlie
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Product Development and Engineering Checkpoint Delta
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Product Development and Engineering for Medical Devices (Level 1)
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Product Development and Engineering for Medical Devices (Level 2)
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Product Development and Engineering for Medical Devices (Level 3)
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Product Development and Engineering for Medical Devices (Level 4)
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Protecting your Data from Risk: To, From, and In the Cloud
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Quality Assurance Management Checkpoint Alpha
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Quality Assurance Management Checkpoint Beta
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Quality Assurance Management Checkpoint Charlie
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Quality Assurance Management for Medical Devices (Level 1)
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Quality Assurance Management for Medical Devices (Level 2)
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Quality Assurance Management for Medical Devices (Level 3)
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Quality Assurance Management for Medical Devices (Level 4)
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Quality Spotlight: Trials & Triumphs of Complaint Handling
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Regulatory Affairs Checkpoint Alpha
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Regulatory Affairs Checkpoint Beta
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Regulatory Affairs Checkpoint Charlie
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Regulatory Affairs Checkpoint Delta
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Regulatory Affairs for Medical Devices (Level 1)
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Regulatory Affairs for Medical Devices (Level 2)
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Regulatory Affairs for Medical Devices (Level 3)
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Regulatory Affairs for Medical Devices (Level 4)
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Regulatory Pathways Round Table
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Remote audits
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Risk Management from a Regulatory and Product Development Perspective
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Risk Management Plan Template
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Significant Risk vs. Nonsignificant Risk Devices - What's the Difference?
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Standards and Pathways to the EU Medical Device Market
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Standards and Pathways to the USA Medical Device Market
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The Art of Defining Design Inputs and Design Outputs
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The Basics of Bill of Materials (BOMs) for MedTech
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The Basics of Cybersecurity for Medical Device Manufacturers
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The Beginners Guide to Design Verification and Design Validation for Medical Devices
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The Definitive Guide to Change Management for Medical Devices
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The Definitive Guide to Responding to FDA 483 and Warning Letters
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The Future of Health and Medicine: Where Can Technology Take Us?
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The Importance of Design Controls
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The Ins and Outs of Supplier Management
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The Journey Continues: What to Know for US FDA Class I and other Global Regulator UDI Requirements
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The Risk Management Process and ISO 14971
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The Ultimate Guide to CAPA
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The Ultimate Guide to Design Controls for Medical Device Companies
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The Ultimate Guide to Document Control for Medical Device Companies
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The Ultimate Guide to ISO 13485:2016 Quality Management System for Medical Devices
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The Ultimate Guide to Training Management for Medical Device Companies
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The Wait is Over: Assessing the Proposed Rule Aligning FDA's Medical Device Quality System Regulation with ISO 13485:2016
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The Who, What, and When of IVDR Enforcement
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This is not your grandmother's validated state!
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Tips for Working with Contract Manufacturing
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Ultimate Guide to 21 CFR Part 820 - FDA's Quality System Regulation for Medical Devices
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Ultimate guide to Agile Design and Development for Medical Devices
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Understanding the Medical Device Single Audit Program (MDSAP): Pros, Cons, and How to Prepare
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Using the Bucket Method for Medical Device Risk Management
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What is a Medical Device?
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What is the Best Way to Structure a Risk Management File
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MDSAP Foundation Training
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Introduction to Quality Management for Medical Devices and ISO 13485
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A Resource Pack for the MedTech Entrepreneur
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The Entrepreneur's Guide to the Medical Device Industry
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Entrepreneur's Guide Welcome Course
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Foundations of Safe Medical Device Development and Manufacturing
Regulatory Foundations for MDSAP
This plan includes the Introduction to Quality Management (ISO 13485) and MDSAP Foundations Training premium courses as well as the Advanced Exclusive content.
Why Advance?
The Advance membership is your ticket to continuous MedTech learning! It includes the following...
- 100+ exclusive pieces of content
- Curated Success Paths
- Special discounts through our "Learning Alliances" program
- Learning dashboards and analytics for teams.
Premium Courses
This specialized membership program also includes 2 of our Premium Courses that we feel are the foundation for product development excellence.
The two premium courses included are...
The two premium courses included are...
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