Industry Perspectives
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Your Best Chance At Regulatory Compliance For Combination Products: Integrated Development
9/14/2023
The FDA now defines a prefilled syringe, a product that was at one point considered “packaging” for a drug, as a constituent part of a combination product. The ultimate combination of the drug, its package, and its delivery device means that during development and manufacturing you need to combine both drug and device current good manufacturing practices (cGMPs) and quality approaches.
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5 Best Practices For Responding To FDA Form 483 Inspection Observations
9/1/2023
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 5-step action plan to make sure the findings are properly addressed.
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Korean GMP: MFDS Requirements For On-Site And Document Audits of Medical Device Manufacturing Plants
8/8/2023
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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The Critical Role Of Risk Mitigation & Vertical Integration In Successful Micro Molding
7/31/2023
In this exclusive Q&A article, Alex Anderson, Sales Engineer at Accumold, systematically explores the crucial implications of vertical integration in micro molding projects.
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Materials Innovation: Propelling A New Era For Medical Devices
7/19/2023
Medical device designers are increasingly challenged by the limits of what the materials at their disposal can do. How can device manufacturers begin to consider what the alternatives to standard materials might allow for in a given medical application? And what would that process look like?
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Biocompatibility Testing Tips To Speed Your Medical Device To Market
7/12/2023
Biocompatibility testing is a regulatory safety requirement that assures a device and its components are compatible with the biologic environment in which the device will be used. Maintain your critical path to market with these tips.
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Beat Your Medtech Competition To Market Launch With Streamlined Processes
7/11/2023
With rampant competition in the medtech market, streamlining development processes lies in the ability to compress timing while maintaining the integrity of the final product. Let's look at how to do this.
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Steps To Develop A Leak Test For Implantable Medical Devices
7/7/2023
If you're developing an implantable medical device, you need to prove to regulators that it will function safely and effectively 10 years after implantation. However, there is no standard approach to follow, and before setting acceptance criteria, you'll need to find a way to test for leaks. Here is one effective method.
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Key Considerations In Selecting A Robotic Solution For Endotoxin Testing
7/6/2023
The U.S., European, and Japanese Pharmacopoeias require testing for bacterial endotoxin in pharmaceutical products, water, intermediates, and medical devices. This article shares key criteria for those of us who are looking to select an automated/robotic endotoxin detection system.
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Optimizing CMO Partnerships
7/5/2023
Industry experts discuss best practices and tips across a range of topics, including program management, automation, and secondary services.