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By Yu Zhao, Bridging Consulting | The FDA introduced the concept of the predetermined change control plan to address the dynamic nature of medical devices, particularly those using software and AI. Bridging Consulting conducted a data-driven study and shares the key findings. |
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| Design Verification Testing Of Combination Products | Article | By Mike Ulman, West Pharmaceutical Services, Inc. | Developing a combination product and seeking a list of tests to complete design verification testing? Review the details for planning, design inputs, design outputs, and design verification. |
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| The Impact Of PFAS Regulations On Drug Delivery Devices | Article | By Shalene Thomas, Battelle | By adopting a strategic approach and embracing necessary measures, the medical device industry can transform regulatory challenges surrounding PFAS into opportunities for innovation and growth. |
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| 5 Common Medical Injection Molding Business Mistakes | Article | Medbio | A full-service medical injection molding company should focus on what is necessary to help customers be highly successful by keeping them at the forefront of technology and in front of their competition. |
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