Posted on September 18, 2024 by DeviceLab
Entering the medical device market requires substantial upfront investments in research and development, clinical evaluations, regulatory approvals, manufacturing capabilities, and commercialization activities. Due to these high costs and risks, having a well-defined market entry strategy is crucial for successfully launching and commercializing a new medical device. Without a robust strategy in place, companies can end […]
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Posted on September 4, 2024 by DeviceLab
The healthcare industry has undergone rapid technological innovation in recent years. The emergence of the Internet of Things (IoT) has led to connected, data-driven medical devices that are transforming patient monitoring, treatment delivery, and healthcare operations. It is estimated that the global IoT healthcare market will reach $534.3 billion by 2025. This proliferation of networked […]
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Posted on August 28, 2024 by DeviceLab
Materials are a critical component of medical device design and performance. The materials used in devices that interact with the human body have a direct impact on patient safety, device efficacy, and overall functionality. Selecting the right materials is key to mitigating risk and meeting regulatory requirements. This article covers the key considerations and criteria […]
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Posted on August 14, 2024 by DeviceLab
Medical devices play a critical role in healthcare, diagnosing conditions, treating patients, and improving quality of life. From simple bandages to complex MRI machines, medical devices encompass a wide range of products that have become essential components of modern medicine. However, successful medical device development requires navigating a complex regulatory landscape. Companies must follow structured […]
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Posted on August 9, 2024 by DeviceLab
Designing Fundus and Retinal Optical Devices Fundus and retinal optical devices are essential tools in modern ophthalmology. The retina at the back of the eye is a critical part of the visual system responsible for capturing and sending images to the brain. Diagnosing and treating retinal diseases require precise and detailed imaging, where these devices […]
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Posted on August 7, 2024 by DeviceLab
Optical devices play a crucial role in modern ophthalmology by providing detailed images of the eye, allowing for accurate diagnosis and treatment of various eye conditions. The precision and clarity of these devices, such as fundus cameras and retinal imaging systems, are essential for detecting diseases early and monitoring their progression. The design and development […]
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Posted on July 24, 2024 by DeviceLab
Medical devices play a critical role in healthcare, enabling clinicians to diagnose conditions, monitor patients, and provide treatment. Class 1 medical devices, the lowest risk categorization, are vital technologies that make up a significant portion of devices on the market. These include ubiquitous products like bandages, stethoscopes, and other devices that provide basic safety and […]
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Posted on July 19, 2024 by DeviceLab
Wireless remote patient monitoring (WRPM) enables continuous care of patients outside traditional healthcare settings by using technology to remotely track health data. WRPM involves collecting patient health and medical data like blood pressure, blood oxygen levels, weight, electrocardiograms, and more using connected devices and sensors. This data is wirelessly transmitted to healthcare providers to monitor […]
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Posted on July 10, 2024 by DeviceLab
The design history file (DHF) serves a critical function in medical device development by providing documentation of the product design process. As a key component of technical files submitted for regulatory approval, the completeness and integrity of the DHF is imperative. However, assembling a robust DHF that meets all regulatory requirements presents some common challenges. […]
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Posted on June 5, 2024 by DeviceLab
The 510(k) submission process is the regulatory pathway that medical device manufacturers must follow to receive FDA clearance to market a new device in the United States. Under section 510(k) of the Food, Drug, and Cosmetic Act, device manufacturers must submit a premarket notification to the FDA demonstrating that the new device is “substantially equivalent” […]
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