Regulatory Foundations for FDA

Contents

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