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By Tim Sandle, Ph.D. | Developing an effective combination product can be easily undone if it is not used correctly, and errors made by patients or clinicians are often a direct result of design limitations. To support the co-packaged design process, the FDA has issued a new guidance document titled Application of Human Factors Engineering Principles for Combination Products: Questions and Answers. |
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By Yu Zhao, Rene Hardee, Randy Horton, Ashley Miller, Michael Iglesias, Roma Williams, and Jaden Maloney | Many medical device manufacturers will continue to make changes after the initial commercialization of the device, and such post-market changes can be planned or unplanned. As the first article in a three-part series about predetermined change control plans, this article discusses the six steps involved with post-market change controls and current FDA guidance regarding 510(k) device software modifications. |
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By Gunjan Bagla, Amritt Inc. | India's government has approved a new initiative aiming for a 20% annual growth rate for medical devices, which is dubbed as a "Sunrise Sector." The initiative will streamline regulations, add a new push for manufacturing capacity, and strengthen opportunities for R&D collaboration. The aim is for both local and global companies to benefit. |
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| A New Mindset For Combination Product Development | Article | By Asmita Khanolkar, SMC Ltd. | As we balance the time-to-market and risk for novel therapies, we must anticipate changing needs for combination device development, highlighting the technological paradigm shift. |
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| Annex 1 Compliance Guidelines For Biological Indicator Users | Article | By Crystal Hostler, Mesa Laboratories | Gain a deeper understanding of the requirements, guidelines, and best practices for Annex 1 compliance whether you're in pharmaceuticals, healthcare, or any field utilizing biological indicators. |
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