The Critical Role of Medical Device Audit Compliance: Why Regular Audits Are Necessary

by Jeremy Moore | Sep 11, 2024 | Medical Device Auditing, Compliance and Regulatory Guidance

The Critical Role of Medical Device Audit Compliance: Why Regular Audits Are NecessaryThe Importance of Medical Device Audit ComplianceThe Role of Regular Audits in Continuous ComplianceWhat Are Regular Audits?Types of Audits: Covering All BasesWhy Frequency Matters:...

FDA Breakthrough Device Designation: Benefits, Criteria, and Application Process

by Jeremy Moore | Sep 4, 2024 | US FDA Regulatory Requirements, Compliance and Regulatory Guidance

Introduction to FDA Breakthrough Device Designation?What is the FDA Breakthrough Device Designation?Benefits of FDA Breakthrough Device DesignationAccelerated Development and ReviewPriority Review and Interaction with FDAReimbursement AdvantagesMarket...

The Complete 7-Step CAPA Process for Medical Devices

by Jeremy Moore | Aug 27, 2024 | Compliance and Regulatory Guidance, Quality Management

Understanding the CAPA Process for Medical Devices: Your Path to Compliance and QualityWhat is the CAPA process for Medical Devices? Defining CAPA:The Role of CAPA in the Medical Device Industry:Regulatory Requirements:Why the CAPA Process for Medical Devices is...

Top 5 Common Pitfalls in FDA Pre-Submission Meetings and How to Avoid Them

by Jeremy Moore | Aug 7, 2024 | Compliance and Regulatory Guidance, US FDA Regulatory Requirements

Introduction to FDA Pre-Submission MeetingsUnderstanding FDA Pre-Submission MeetingsCommon Pitfalls in FDA Pre-Submission Meetings1. Lack of Preparation2. Inadequate Data or Documentation3. Miscommunication or Lack of Clarity4. Not Defining Objectives Clearly5....

Quality Assurance vs Quality Control in Medical Devices: Understanding the Key Differences

by Jeremy Moore | Jul 24, 2024 | Quality Management, Compliance and Regulatory Guidance

Introduction to Quality Assurance vs Quality Control in Medical DevicesUnderstanding Quality Assurance (QA) for Medical DevicesWhat is Quality Assurance for Medical Devices?The Role of Quality Assurance in Medical DevicesKey Activities in Quality...

Choosing the Right Path: 510(k) vs De Novo Pathways for SaMD

by Jeremy Moore | Jul 19, 2024 | Software as a Medical Device, Compliance and Regulatory Guidance, Product Development

Unlocking Regulatory Success: 510(k) vs De Novo Pathways for SaMDUnderstanding the 510(k) PathwayDefinition and Background of the 510(k) Pathway:Requirements of the 510(k) Pathway:Process for the 510(k) Pathway:Advantages of the 510(k) Pathway:Limitations of the...