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Regulatory Compliance and Software-as-a-Service (SaaS)
As of 2026, a significant portion of medical device "servicing" happens in the cloud. With the full implementation of the EU Medical Device Regulation (MDR) and updated FDA Quality System Regulations, manufacturers and service providers must maintain a "Digital Thread" for every piece of equipment.
This document highlights the rise of SaaS-based Compliance Platforms. These systems automatically log every calibration, software patch, and hardware repair into a secure, auditable database. In 2026, "Compliance-as-a-Service" is a major market segment, where third-party providers manage the regulatory documentation and quality assurance for entire hospital systems, ensuring that all devices meet the rigorous ISO 13485 standards for safety and efficacy.