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By Adish Bhatnagar, independent consultant and freelance GxP auditor | The FDA has finalized a guidance on the circumstances that constitute delaying, denying, limiting, or refusing a drug or device inspection. They also provide reasons that may cause drugs or devices to be adulterated under the FD&C Act. |
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By Kateryna Hronska and Kamran Zamanian, iData Research | This article shares new market research focusing on three segments of the U.S. breast reconstruction market: allografts, xenografts, and synthetics. |
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By Alex Vasiev, principal engineer, Springboard pro | In medical device development, the proof of feasibility stage often includes preliminary testing, but also detailed technical, usability, manufacturability, regulatory, and commercial assessments. |
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| Current Trends In Medical Kit Packaging | Article | B. Braun OEM Division | Today’s version of the medical procedure kit comprises stackable, efficient, sterile, and identifiable trays or pouches stocked with essential equipment for specific surgeries, tests, and examinations. |
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| Why Engineers Water Down Part Design | Article | By Craig Tappe, Accumold | Discover why designing for manufacturability shouldn't mean settling for less, but rather striving for innovation with every micron. |
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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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