You have done your Software Risk Analysis and have identified your Firmware to be of Software Safety Class C. What next? There are 3 points of the IEC 62304 ...

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The FDA recently published a new guidance on Cybersecurity and software in medical devices: “Cybersecurity in Medical Devices: Quality System Considerations ...

“Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions | FDA” is a new document produced by the FDA that ...

Whatsapp Share Tweet Share More and more people today are ...

Most if not all major devices (including medical devices) throughout the world have some form of a bootscreen. This often flashy but sometimes simple ...

Whatsapp Share Tweet Share Can pacemakers be re-used? The answer is ...

Understanding Post-Market Surveillance:In the fast-paced world of medical technology, the journey of a medical device doesn’t end with regulatory approval. It ...

The FDA is making significant strides in integrating real-world data (RWD) into the regulatory framework for medical devices. A recent 40 page draft guidance, ...

FDA Quality Management System Regulation (QMSR)In February 2022, FDA released proposals for aligning their Quality System Regulation (QSR) with the commonly ...