FEATURED EDITORIAL
Two Key Security Precautions To Protect Your Device — And Your Patients
A physically secure device doesn't ensure data security, just as shoring up data connectivity vulnerabilities doesn't preclude bad actors from physically damaging a device. But, a vulnerability assessment and penetration test can greatly improve your understanding of how safe a device is from a cybersecurity standpoint.
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![Computer security-alert-GettyImages-1265030703]( "FDA’s Grace Period For Medical Device Cybersecurity Is Over. Are You Ready?")
The FDA had established a grace period for all medical device manufacturers to ensure that you are incorporating cybersecurity during the design and validation of cyber devices. The end date of the grace period, and the seminal date in medical device cybersecurity enforcement, is Oct. 1, 2023. Are you prepared?
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![CAD Software-design syringe-GettyImages-1334646166]( "A Brief Guide To ISO 13485’s Design Controls In Medical Device Development")
Design controls play a crucial role in the medical device development process by providing a systematic approach to manage risks, design requirements, and verification and validation activities. Let's explore the key elements of ISO 13485 that will help you manage the process effectively.
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![Union arrow-GettyImages-1169332211]( "Your Best Chance At Regulatory Compliance For Combination Products: Integrated Development")
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.
INDUSTRY INSIGHTS
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![Knowles - High Q Capacitors]( "High Q Capacitors – Roles And Specifications")
High Q Capacitors – Roles And SpecificationsThe Q factor measures a capacitor's efficiency in storing and dissipating energy at a specific frequency, with a high Q indicating low energy loss and suitability for low-power, stable applications.
After 5 years of work, Accumold has developed a high-volume micro injection molding method for thin-wall cannulas, replacing the expensive and less efficient extrusion process for medical device OEMs.
In the fast-paced healthcare world, sterilization is crucial for patient safety, with RFID technology emerging as a game-changing solution to improve medical device management and prevent infections.
Explore the versatile use of piezoelectric microfluidic devices in precise liquid handling for diverse applications including genomics, diagnostics, cytometry, and lab automation.
Learn how a biodegradable polymer platform that is compatible with many substrates can enable several applications as a drug eluting carrier with a wide variety of APIs.
SOLUTIONS
At SMC Ltd. we understand your desire to have a single point of contact for your full medical device. With SMC’s demonstrated strength in IQ/OQ/PQ validation, our network of established and qualified suppliers, and our experience in custom manufacturing, we have the comprehensive resources in place to manage your program from conceptual design to final distribution.
The IMH Pressure Relief Valves for plastic incorporate a simple, press-in design for easy installation. With features including metal to metal seating, the valves provide low leakage, highly repeatable cracking pressure, and compatibility with a wide range of fluids and gases.
Detergent 8 is concentrated to save you money, biodegradable, and readily disposable. Its penetrating wetting power saves you time. It’s free rinsing to give you reliable results and no interfering residues.
Stevanato Group uses proven technologies to develop customized solutions for the efficient sub-assembly and final assembly of your pharmaceutical and medical products. We blend our 30-year expertise and your needs in order to support you all the way from clinical trials to fully-automatic high volume production.
Qosina offers the largest stock inventory of medical valves including check valves, relief valves, hemostasis valves, luer-activated valves, tuohy borst adapters and drain valves.
Canon's brushless servomotors are compact in size and provide high output power. Two types are offered with quick response and smooth rotation. Various custom options can be incorporated to fit your applications.
FEATURED SUPPLIERS
Accumold® is a high-tech manufacturer of precision micro, small and lead frame injection molded plastic components
B. Braun’s OEM Division delivers complete contract manufacturing capabilities for a multitude of markets including surgical, pharmaceutical and biotech. With three global divisions (Europe, Asia-Pacific and North America), B. Braun’s OEM Division offers wide-ranging and complementary capabilities resulting in new products, expanded production, cost efficiencies, and country-specific knowledge.
MED DEVICE ONLINE CONTENT COLLECTIONS
Artificial Intelligence and Machine Learning are taking the life sciences world by storm. Do you know how to harness its power for your medical device? Check out our latest e-book which examines the opportunities AI and ML offer to both complement and supplement human intelligence in the medical device industry.
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