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...
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:...
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...
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...
by Jeremy Moore | Aug 20, 2024 | Software as a Medical Device
Streamlining Medical Device Manufacturing with Lean Product DevelopmentThe Transformative Potential of AI in SaMDKey OpportunitiesConsiderations and ChallengesData Privacy and Security Regulatory Compliance Ethical Concerns Technical and Infrastructure Challenges Loss...
