Archive
Regulatory Requirements for Class 1 Medical Devices
Posted on July 24, 2024 by DeviceLabMedical 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 […]
Wireless Remote Patient Monitoring: Enabling Continuous Care Beyond Hospital Walls
Posted on July 19, 2024 by DeviceLabWireless 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 […]
Common Pitfalls to Avoid in Creating a Design History File
Posted on July 10, 2024 by DeviceLabThe 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. […]
