Compatibility and Regulation

DICOM Standard Compliance

MODALIZER+ implements the DICOM standard's networking, file format, and service classes – Storage, Query/Retrieve, Modality Worklist, Modality Performed Procedure Step, Storage Commitment, and Verification – so studies it creates or transmits behave exactly as any other DICOM-compliant modality on your network. See the full DICOM Conformance Statement for the specific SOP classes, transfer syntaxes, and network services MODALIZER+ supports.

IHE Guidelines

MODALIZER+ follows IHE (Integrating the Healthcare Enterprise) integration profiles for imaging workflow, functioning as a Virtual Acquisition Modality under the IHE Scheduled Workflow integration profile. This ensures that patient context, procedure scheduling, and image acquisition steps interoperate correctly with the RIS, PACS, and other systems already deployed in your imaging environment, rather than requiring custom integration work.

HIPAA and Patient Data Protection

MODALIZER+ was developed according to HIPAA guidelines for handling Protected Health Information (PHI). All DICOM network communication supports Secure DICOM Networking (TLS 1.2) over TCP/IP, and the application stores acquired studies locally in standard DICOM files, with no proprietary formats or hidden attributes, and no data sent to third parties as part of normal operation.

Quality Management System (21 CFR Part 820)

H.R.Z. Software Services LTD has implemented a Quality Management System (QMS) that follows the FDA's medical device Quality System regulation, 21 CFR Part 820. This QMS governs how MODALIZER+ is designed, developed, tested, and maintained – documented and controlled processes from requirements through release, applied consistently across every version of the product.

This reflects H.R.Z.'s ongoing commitment to quality and regulatory rigor in the medical imaging software it builds – not a one-time exercise, but the framework MODALIZER+ continues to be developed under today.

Powered by MODALIZER-SDK

MODALIZER+'s underlying DICOM engine is MODALIZER-SDK, H.R.Z.'s DICOM toolkit for medical device manufacturers. It's the same SDK trusted by major medical imaging device manufacturers to build DICOM connectivity into their own products, and it's already running inside numerous FDA-regulated medical imaging devices on the market today. MODALIZER+ isn't running a DICOM implementation written just for this one application – it's built on the same proven, field-tested engine our SDK customers depend on.

How We Build MODALIZER+

MODALIZER+ is built by a small team of engineers who specialize in DICOM and healthcare imaging – not a large organization where requirements pass through multiple hand-offs before reaching the people who write the code. That's a deliberate choice: it keeps the distance between a DICOM standard requirement, an IHE integration profile, and the code that implements it as short as possible, with direct accountability for getting it right.

Day to day, that work runs on the same tools most modern software teams rely on: Git for version control, so every change to MODALIZER+ has a full, auditable history, and Jira for tracking requirements, issues, and releases – the same structured, documented workflow our Quality Management System requires, not a separate process bolted on to satisfy it. Builds are automated through TeamCity, and every release goes through automated testing before it ships, with every change traceable back to why it was made.