Introduction to IEC 60601
The IEC 60601 standard is a globally recognized benchmark for the safety and effectiveness of medical electrical equipment. It ensures that devices used in healthcare settings meet stringent requirements to protect patients, operators, and the environment. For engineers working in the medical device industry, understanding IEC 60601 is crucial to designing compliant and reliable products.Overall […]
BLE Connection and Bonding Issue with iPad A16 (11th Gen)
The Issue While validating an iPad app that communicated over BLE to a Windows central (intel chipset), an issue with newer iPad models (iPad A16, acting as a BLE peripheral) was identified. It was expected that the central device (windows) should initiate bonding/connection and complete successfully, as with earlier. However this did not happen and […]
Agile based development with IEC 62304
Agile methodologies are increasingly popular in software development due to their flexibility and iterative approach. However, developing a 62304-compliant codebase in an agile environment requires additional processes to ensure that the regulatory requirements are met without compromising the benefits of agility. Key Agile Strategies for IEC 62304 Compliance Incremental Development with Defined Iterations Break the […]
Introduction to IEC 62304 via the V-Model
IEC 62304 is an international standard that defines the life cycle requirements for medical device software. It provides a framework for the safe design and maintenance of software used in medical devices, ensuring that risks are managed effectively throughout the software’s life cycle. Its important to stress that 62304 discusses software in a medical medical […]
