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By KangKeun (Daniel) Lee, Freyr Solutions | If your medical device or in vitro diagnostics company is looking to enter the South Korea market, you will need to comply with the Korea good manufacturing practice (KGMP) standards and requirements. This article shares a thorough overview of the requirements, including new information about audits that went into effect at the beginning of 2023. |
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By Allan Marinelli and Howard Mann | Computer software and systems validation testing are used to validate software under GxP environments. Parts 1 and 2 of this article series shared agile methodology with regard to the phases of planning, team structure and collaboration, software architecture, and more. In this final installment, the author discusses software release, configuration and change management, CAPA, and more. |
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By Susan Shockey, Clarkston Consulting | How you respond to FDA Form 483 observations will determine if they escalate into more serious consequences, such as a warning letter or enforcement action. You don't want that. Follow this five-step action plan to make sure the findings are properly addressed. |
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| Improving Medical Device Sustainability | Article | By Molly Wagle, DSM Biomedical | Product design, production methods, and supply chain can be leveraged to positively impact sustainability through effective planning. |
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