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Articles on QMS, compliance, audits, validation, and digital transformation for regulated industries.
194 articles in Medical Device
How to Build a Quality Objectives Program That Satisfies ISO 13485 Section 5.4
Learn how to build a quality objectives program that meets ISO 13485 Section 5.4 requirements, passes audits, and drives real improvement in regulated companies.
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How to Conduct a Gap Analysis for ISO 13485 or FDA QMSR Certification
Step-by-step guide to conducting a QMS gap analysis for ISO 13485 or FDA QMSR certification. Includes what to assess, how to score gaps, and how to build a remediation plan.
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How to Build a Nonconformance Trending Report That Drives Continuous Improvement
Learn how to design a nonconformance trending report that satisfies FDA and ISO 13485 requirements and gives quality leaders data they can actually act on.
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How to Write a Quality Manual: ISO 13485 and FDA QMSR Requirements with Template
A practical guide to writing a quality manual that satisfies ISO 13485, FDA QMSR, and third-party auditors. Includes structure, required sections, and writing tips.
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Corrective Action Effectiveness Checks: How to Verify CAPA Worked Under FDA and ISO 13485
Learn how to design corrective action effectiveness checks that meet FDA and ISO 13485 requirements and break the repeat-CAPA cycle for good.
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ISO 13485 Clause-by-Clause Breakdown: Understanding Every Section and Its QMS Implications
A detailed clause-by-clause breakdown of ISO 13485:2016 requirements, what each section demands from your QMS, and the most common audit findings per clause.
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21 CFR Part 820 Design Controls: Detailed Requirements and Common Audit Findings
A detailed breakdown of 21 CFR Part 820 design control requirements, the design history file, common FDA audit findings, and how QMSR aligns with ISO 13485.
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How Long Does ISO 13485 Certification Take? A Realistic Timeline for Medical Device Companies
ISO 13485 certification takes 6 to 18 months depending on your starting point. Here is a realistic phase-by-phase timeline for medical device companies.
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Medical Device PMA (Premarket Approval) Quality Requirements: What FDA Expects
Understand what FDA expects from your quality system when pursuing Premarket Approval (PMA) for a medical device. Covers QMS, design controls, and PMA supplements.
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Medical Device 510(k) Submission: QMS Requirements and Design Control Documentation
Understand the QMS and design control documentation FDA expects during 510(k) review, from device classification through predicate device comparison and CAPA.
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Laboratory QMS: ISO 17025 vs ISO 13485 — Which Standard Applies and When
Understand the differences between ISO 17025 and ISO 13485 for laboratory quality management and which standard applies to your specific testing operations.
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Real World Evidence (RWE) and Data Quality: What FDA’s Guidance Means for Your QMS
Understand what FDA's RWE guidance means for your QMS data quality requirements. Practical steps for pharma and medical device quality teams managing real-world data.
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