SynthQMS — the platform medical-device companies actually run on.

Because customers buy it. SynthQMS is the integrated QMS + CRM control plane Synthology runs on internally; it's also a standalone product available to other medical-device companies, imaging-IT vendors, and any organization that needs ISO 13485-structured QMS with a CRM bolted in. Not a medical device itself -- it's the platform that helps you operate your medical-device business compliantly. Different category from XyDromatics; same family.

No. SynthQMS is fully standalone-licensable. Many customers buy it without any XyDromatics products. The integration benefit when you DO run XyDromatics products is that complaints / MDRs / released-versions for those products flow naturally into SynthQMS without separate tooling. But the QMS + CRM functions stand on their own.

SynthQMS lives in a slightly different niche. The big incumbents (MasterControl, Veeva) are purpose-built QMS platforms with deep regulatory tooling and high price points; they typically don't have CRM. The lighter QMS-as-SaaS players (Greenlight Guru, Qualio) are accessible for early-stage med-device but also QMS-only. SynthQMS combines QMS + CRM in one platform, ships cross-platform (Windows + Linux), and comes with the Booth PWA for trade-show lead capture and the accounting integrations (QBO + Xero) that growing companies actually need. Different sweet spot from the QMS specialists, but operationally simpler for organizations whose revenue function and quality function are run by overlapping teams.

SynthQMS is 21 CFR Part 11-aligned: electronic-signature support per §11.50 with required-reason text, two-person sign-off where applicable, audit trails per §11.10(e), and tamper-evident hash-chain audit logs. Whether your specific deployment meets Part 11 in practice depends on your configuration, your training program, your validation package, and your operational discipline. SynthQMS gives you the technical foundation; the compliance program is yours to maintain. Same as every QMS product -- "Part 11 compliant" is a property of how you run the system, not just what the system can do.

Yes, structurally. The module set maps directly to ISO 13485 clauses: §4.2 document control, §6.2 training records, §7.3 design change control, §8.2 customer feedback / complaints, §8.5 CAPAs, §5.6 management review. Auditors walking the system find the artifacts they expect to find. SynthQMS is used internally to run our own ISO 13485-aligned QMS, so the eat-your-own-dogfood validation is built in.

SynthQMS's controlled-document workflow, RBAC, audit trail, and change-management surface are exactly the controls a SOC 2 audit walks. Synthology's own SOC 2 Type II readiness program (DOC-2026-253) treats SynthQMS as the system of record for the control framework. Customers running SynthQMS inherit that structural fit.

Both, customer's choice. SynthQMS deploys cross-platform (Windows + Linux), runs against PostgreSQL / SQL Server / Oracle, and works on-prem, customer-cloud, or in a Synthology-managed deployment. The SharePoint document mirror gives an off-host backup wherever the primary deployment lives. We do NOT operate a multi-tenant Synthology-hosted SaaS as the default -- single-tenant deployments are the standard.

Surprisingly, yes. Trade-show lead-capture is a real workflow pain point for med-device companies (HIMSS, RSNA, AHA, dozens of regional shows). The PWA replaces paper lead-capture sheets, the "type 200 leads from photos of business cards" data-entry day after every show, and the lead-quality degradation that comes from delayed entry. Cloudflare Tunnel integration means it works on convention WiFi (and survives when convention WiFi briefly doesn't). It's a small feature with outsized ROI for organizations that work the trade-show circuit.

Yes -- Windows and Linux. MSI installer for Windows, self-contained Linux tarball for Linux. Same parity as the rest of the Synthology product family (except the Pathology Engine, which is Windows-only).