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Marked for Life
Inside the world of safe medical device laser marking
New NIST Reference Strengthens Quality Control for Biological Drugs
Helps biopharmaceutical manufacturers detect particulate impurities to maintain product quality, reduce costs
Pharmaceutical Serialization
Ensuring regulatory compliance through strategic implementation
Carrying Out a Supplier Audit
When and how to audit your suppliers
5 Key Elements of an Effective CAPA System
Common challenges medtech companies face, and how to overcome them
How Tech-Enabled Solutions Can Simplify BRCGS Packaging Materials
Implementation and audit readiness
FDA Guidances on AI-Enabled Devices
Where AI stands in 2025
How to Avoid FDA Warning Letters
And how to not get to that point in the first place
Facing Medtech Uncertainty
How medical device companies are navigating current economic conditions
2025 Medical Device Industry Report
Quality challenges, regulatory complexity, and economic uncertainty
Three Insights on Medtech Product Development
Take it from an ex-FDA investigator
Enhancing Compliance Through Quality Risk Management
Building resilience and reliability
AI in Medical Device Manufacturing
And how it’s transforming an industry
How Testing Automation Reduces Risk and Elevates Quality Assurance
Automation equips organizations to keep pace with quick development cycles
Common Mistakes in ISO 27001 Implementation
And how to avoid them
Medical Device Compliance
Regulations, standards, and solutions
Critical Aspects of Quality Management Systems
Focusing on the validation process
Real-World Data and Real-World Evidence
When and how to use them
How Technology Supports ALCOA Principles
Quality management software strengthens data integrity in life sciences
Healthcare Cybersecurity
Diagnosing risks, prescribing solutions

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