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By Yu Zhao, Rene Hardee, Randy Horton, Ashley Miller, Michael Iglesias, Roma Williams, and Jaden Maloney | This is the third and final installment in a three-part article series on post-market change controls and implementing a predetermined change control plan (PCCP) for Class II software as a medical device (SaMD) products beyond artificial intelligence/machine learning (AI/ML). |
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| Critical Cleaning For 3D Printing In The Life Sciences | White Paper | By Jeff Phillips, Alconox Inc. | Here, we focus on the critical cleaning of hard surfaces utilized in 3D printing processes across industries, such as extruded plastics, photosensitive substrates, metals, and metal alloys. |
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| Micro Injection Molding For Thin Wall Drug Delivery Components | Case Study | By Gary Hulecki, MTD Micro Molding | There are many types of challenges that can cause a high-precision micro medical molding project to fail, including delays in validation, achieving multicavity capabilities, and product launch issues. This case study presents a customer that encountered all of these challenges at once and looked to MTD Micro Molding to complete the product validation and preproduction runs that a competitor could not complete for them. |
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| Cultural Audits: What Are They And Why Are They Essential? | Article | B. Braun OEM Division | The medical device industry is familiar with quality audits, but it is less familiar with the benefits of having a cultural audit to assess the competence, dedication, and passion that each party brings to the table. |
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| Selecting The Best Pinch Valve For Your Application | Application Note | The Lee Company | There are two primary types of pinch valves used in the medical and scientific industries: external and internal. Each has benefits and drawbacks, depending upon its end use. The core functionality of a pinch valve is a flexible flow path element that is compressed by an external plunger or pinch block. |
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