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Articles

Practical writing on getting medical device software through the FDA and keeping it there: the standards, the submissions, and the engineering behind them.

Software Engineering & Integration

Is It Time for a User Interface Refresh?

A UI refresh is worth considering when user feedback, evolving needs, an aging visual design, or a backend platform update signal your interface no longer serves users, your brand, or FDA-regulated usability requirements effectively.

Updated September 2026

AI & Machine Learning

Artificial Intelligence and Machine Learning in Software as a Medical Device

The FDA's AI/ML discussion paper proposes regulating adaptive Software as a Medical Device through a Total Product Lifecycle approach, evaluating Good Machine Learning Practices and a pre-specified plan for algorithm changes rather than a single locked version.

Updated September 2026

Regulatory & Quality

Validating Cloud Software Tools

Cloud software tools can be validated under FDA software validation guidance using continuous validation (automated, on-demand testing) or periodic validation (scheduled testing), chosen by device impact, technical skill, and cost.

Updated September 2026

Regulatory & Quality

Are You IEC 62304 Compliant?

IEC 62304 compliance means your medical device software lifecycle meets international requirements for risk management and documentation alongside ISO 13485 and ISO 14971. Here are the readiness questions to ask first.

Updated September 2026

Regulatory & Quality

ISO 14971 Risk Management and How Updates Impact Usability Engineering

ISO 14971's third edition keeps the core risk management process intact but clarifies key definitions and adds stronger post-market usability data requirements for medical device manufacturers.

Updated September 2026

Cybersecurity

Medical Device Cybersecurity and FDA Section 524B

FDA premarket cybersecurity review is now a statutory requirement under Section 524B, not just guidance. This article covers premarket and postmarket cybersecurity expectations for connected medical devices, including SBOM submissions.

Updated September 2026

Software Engineering & Integration

LIS and EHR Integration for Medical Device Instruments

Medical device instruments must exchange data with LIS and EHR systems using protocols like HL7, ASTM 1394, ASTM 1381, and POCT1-A. The RND Group's LIS Connector reduces manual entry errors and speeds integration.

Updated September 2026

Software Engineering & Integration

Image Processing Projects at The RND Group

Medical device image processing moves through six phases: setup, acquisition, enhancement, segmentation, quantification, and optimization. This article walks through each phase and how The RND Group engineers reliable, high-performance imaging workflows for diagnostic instruments.

Updated September 2026