Industry Insights
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Choosing The Right PCD Configuration For Reliable Sterility Assurance
10/16/2025
Accurate PCD configuration ensures sterility assurance. Learn how to align validation strategies with ISO standards, optimize cycle efficiency, and select the right BI format for EO sterilization success.
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Medical Device PFAS: Managing Compliance And Risks In Manufacturing
10/15/2025
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.
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How A Strategic Partnership Drove Micro Molding Success
10/8/2025
In micro-manufacturing, supplier choice significantly determines success. Explore how one company transformed a struggling production program into a 150-million-part success through trust, scalability, and true strategic partnership.
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Key Considerations For Selecting A Solenoid Valve In Health & Science Applications
10/7/2025
Solenoid valves are vital in medical devices, enabling precise fluid and gas control. Explore customizable, high-reliability valves that optimize performance while conserving space, weight, and power.
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Overmolding: The Basics For Successful Optical Manufacturing
9/24/2025
Optical micro overmolding combines micro molding with lead-frame or insert processes to achieve precision, clarity, and integration, demanding early collaboration to ensure manufacturability, performance, and cost efficiency.
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FAQs On The Revised EU GMP Annex 1: Volume 6
9/21/2025
The revised EU GMP Annex 1 prioritizes a CCS. Learn how to holistically manage microbial, particulate, chemical, and cross-contamination risks to ensure product sterility and patient safety.
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Taking A Best Practice Approach To Contamination Control 
9/21/2025
Implementing the EU GMP Annex 1 requires a holistic, evolutionary Contamination Control Strategy built on standardization, data analytics, and continuous improvement for a zero-defect mindset.
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Laying Supply Chain Foundations That Bring Confidence To Compliance
9/21/2025
Compliance with EU GMP Annex 1 requires a strategic CCS. Learn how a framework based on people, communication, process, and continuous improvement enables systematic, long-term compliance.
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FAQs On The Revised EU GMP Annex 1: Volume 3
9/21/2025
The EU GMP Annex 1 revision, effective August 2023, requires a detailed Contamination Control Strategy. Learn how it impacts global manufacturers, RABS use, and personnel procedures.
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Optimize Packaging Systems For Distribution Integrity
9/13/2025
Ensure your medical devices reach patients safely and compliantly by mastering packaging strategies, testing standards, and distribution best practices.