- Software solutions provider Vector is offering a free evaluation toolkit, called the SDC Evaluation Bundle, for medical technology manufacturers.
- This bundle allows users to analyze the IEEE 11073 SDC (Service-oriented Device Connectivity) standard, evaluate performance, and test new features for interoperability in clinical environments.
The IEEE 11073 SDC standard establishes the foundation for bidirectional data and service exchange between devices from different manufacturers. This standard is primarily intended for connected medical environments, such as operating rooms, emergency departments, and intensive care units.
The kit offered by Vector is designed for development managers, system architects, and software teams to test the integration of the SDC standard into production products. To achieve this, the package includes an embedded software stack and simulation capabilities for Software-in-the-Loop (SIL) and Hardware-in-the-Loop (HIL) testing.
Operational Objectives and Reduced Development Steps
Using this package allows manufacturers to create an initial Proof of Concept (POC) in just a few weeks, simplifying the initial evaluation phase. Leveraging this pre-existing software implementation also aims to reduce the internal development effort for a complex communication interface and mitigate associated technical risks. To support adoption, the offering includes training services and project management support.
Alignment with Regulatory and Normative Requirements
From a technical and regulatory standpoint, the SDC stack incorporates the requirements of fundamental industry standards. The architecture incorporates the IEEE 11073 communication standard, the IEC 62304 medical software lifecycle standard (up to safety class C), and the cybersecurity specifications of IEC 62443-4-1.
Furthermore, when licensing serial projects, Vector provides a documentation package designed to simplify the subsequent regulatory approval process for devices up to Class IIb, in accordance with the European Medical Device Regulation (EU MDR).
Involved in the development of the IEEE 11073 SDC standard and a member of the OR.NET association, Vector contributes to the standardization of equipment interconnection in the medical sector.
