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.
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?
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.
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.
High Q Capacitors – Roles And Specifications
The 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.
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.More Content Collections