Top 5 Common Findings in Medical Device Audits and How to Avoid Them

by Jeremy Moore | Sep 25, 2024 | Medical Device Auditing, Compliance and Regulatory Guidance

Are You Prepared for These Top 5 Medical Device Audit Pitfalls?1. Inadequate Documentation Practices: The Achilles’ Heel of Compliance2. Nonconforming Product Management: A Frequent Culprit in Medical Device Audit Findings3. Ineffective CAPA Processes: A Key...

Medical Device Audit Readiness: Why Preparing for a Medical Device Audit Shouldn’t Be Necessary

by Jeremy Moore | Sep 19, 2024 | Medical Device Auditing, Compliance and Regulatory Guidance

Stop Scrambling. Why Constant Medical Device Audit Readiness is the Key to SuccessThe Pitfalls of Last-Minute Audit Preparations1. Stress and Risk:2. Compliance Gaps:3. Real-World Consequences:The Importance of Maintaining Constant Medical Device Audit ReadinessWhat...

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....