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By Hilde Viroux, PA Consulting | Several rules and regulations have important due dates in 2025 and beyond for which medical device manufacturers should be preparing. | |
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By Mayur Patel, Hilde Viroux, and Emanuel Wasson | FDA’s harmonization of the Quality System Regulation with ISO 13485 was long expected. Aligning 21 CFR 820 with ISO 13485 gives companies one global standard for quality management system compliance. | |
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By Jim Kasic, Boulder iQ | While it isn’t possible to eliminate all cases of misuse, medical device manufacturers can significantly reduce the instances — and chances — through formative studies. This article shares key recommendations. | |
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| Avoiding The Pitfalls Of Rapid Scale In Medtech | Article | By Shawn Thibeault, Accumold | For biotech leaders and R&D managers, anticipating and navigating challenges—from supply chain disruptions to quality control—are critical to sustaining growth and market competitiveness. |
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| Reduce Human Error In Healthcare Operations | White Paper | HID | Implementing an IoT platform powered by RFID enables clinicians to effectively use medical equipment and reduce human error in healthcare processes to ensure higher quality of care. |
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