Social Media and DTC advertising for Medical Device Companies in the USA
Updates on the Gradual Rollout of EUDAMED - 2025 and Beyond
Cybersecurity Considerations for FDA Medical Device Submissions
The European Artificial Intelligence Act: What it is, Enforcement Rules and Governance, Timeline and Penalties for Medical Device Manufacturers
Japan's Regulation on SaMD
FDA's Final Rule Incorporating ISO 13485 into their new QMSR
FDA Publishes the LDT Final Rule
How to Write a Software Architecture Document for Medical Devices
In the field of medical devices, a software architecture document plays a crucial role in ensuring the successful development and implementation of these devices. It serves as a guide for the entire software development process and provides a blueprint of how the software components will be structured and interact with each other.
Key Components of a Software Development Plan According to IEC 62304
Software development is a complex process that requires careful planning and execution to ensure the creation of high-quality, reliable software products. In the medical field, where software plays a crucial role in patient care and safety, the International Electrotechnical Commission (IEC) has developed a standard specifically for medical device software development: IEC 62304.
Understanding the key components of a software development plan according to IEC 62304 is essential for medical software developers and manufacturers to comply with regulatory requirements and deliver safe and effective products.
IEC 62304 Explained
In the world of medical device development, compliance with regulatory standards is crucial. One such standard that plays a significant role in ensuring the safety and effectiveness of medical software is IEC 62304.
Effectively Manage Risks Associated with IVDs
How to implement ISO 13485:2016 in your organization
Implementing ISO 13485:2016 in your organization can be a significant undertaking, but it is necessary for ensuring the quality and safety of medical devices. This article will guide you through the process and provide valuable insights into understanding, preparing, implementing, and maintaining ISO 13485:2016 compliance.