Medical Device Audit Readiness: Why It Shouldn’t Be a Project, It Should Be Your Default State

by admin | Aug 18, 2025 | Fission Software, Medical Device Auditing

The Audit Prep Hamster WheelThe Hidden Costs of Project‑Based Audit PrepRegulators Care About Your State, Not Your TimelineWhat Continuous Compliance Looks LikeA Living Data CoreAn Embedded Quality CultureProactive Risk & Trend MonitoringThe Three‑Step Shift From...

Supplier Audit Best Practices: Building Strong Relationships Without Compromising Quality

by Jeremy Moore | Apr 8, 2025 | Medical Device Auditing, Quality Management

The Balancing Act of Compliance and Collaboration in Supplier AuditsWhy Supplier Audits Are Critical for Medical Device CompaniesThe Common Pitfalls That Hurt Supplier Relationships1. The “Gotcha!” Approach: Why Overly Adversarial Audits Backfire2....

The Important Role of Supplier Audits in Medical Device Manufacturing

by Jeremy Moore | Nov 13, 2024 | Medical Device Auditing

Are Hidden Risks Lurking in Your Supply Chain?Why Supplier Audits in Medical Device Manufacturing MatterWhat Does a Supplier Audit Involve?Best Practices for Conducting Supplier Audits in Medical Device ManufacturingKey Metrics and Success Indicators of Effective...

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:...