Newsletter | December 6, 2025

12.06.25 -- November's Most Popular Articles & Solutions

FEATURED EDITORIAL

A Better Interpretation Of POH In ISO 24971

Understanding and scoring Probability of Harm (POH) requires transparency. Effective risk assessment demands showing the full range of probabilities rather than suppressing values that impact true risk.

Mastering Cultural Intelligence In Global Quality And Regulatory Leadership

As medical device markets globalize, quality and regulatory leaders must transcend regional mindsets. Culturally intelligent leadership unlocks stronger systems and turns global diversity into a competitive edge.

Considerations For Rapid Prototyping In Medical Device Development

Rapid prototyping accelerates medical device development, but speed comes with trade-offs. Developers must balance innovation with risks in cost, reliability, materials, and regulatory readiness.

TOP INDUSTRY INSIGHTS

Regulatory Requirements For Medical Device Manufacturers

Ensure your medical device labeling meets regulatory standards and supports product traceability. Explore key labeling requirements to help protect your business and safeguard patient health.

Getting Started With Product Development Strategies

Simplify and streamline new product development for success. Explore the importance of new product innovation, different process methods, and best practices for optimizing your company’s strengths.

Medical Device PFAS: Managing Compliance And Risks In Manufacturing

Managing global PFAS regulations demands a proactive strategy. Identifying and mitigating both intentional and unintentional sources is key to compliance and ensuring long-term product safety.

TOP RESOURCES

Overview Of Biological Indicator And Sterilization Monitoring Systems

Developing A 'Human Solution' To Autoinjector Design

PET Heat Shrink Tubing

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