RiskWatch
RiskWatch International · Founded 1993 · Annapolis, MD, USA
Medical device risk and compliance platform with ISO 14971, ISO 13485, FDA QMSR, EU MDR, IEC 62366, and IEC 62304 pre-mapped.
Summary
RiskWatch ships a device-friendly risk and compliance assessment platform built around pre-mapped control libraries for ISO 14971:2019 application of risk management, ISO 13485:2016 quality management for medical devices, FDA Quality Management System Regulation (QMSR) under 21 CFR Part 820 effective February 2 2026, EU Medical Device Regulation 2017/745 (MDR) and In Vitro Diagnostic Regulation 2017/746 (IVDR), IEC 62366-1:2015 usability engineering, IEC 62304 medical device software lifecycle, FDA Cybersecurity in Medical Devices premarket guidance finalised October 2023, and 30+ other frameworks. The platform runs on a survey-based assessment engine, a cross-mapped control library that auto-detects shared controls across QMSR and ISO 13485 since the two are now harmonised by reference, and an evidence vault that supports the ISO 14971 risk management file directly. Customers include state agencies, multi-hospital health systems, payers, medical device companies, and contract manufacturers. The pricing model is partially opaque on the public site but Standard at 99 dollars per month and Professional at 36,000 dollars per year are published; the single-tenant deploy architecture means device makers retain full control of design history file (DHF) and design master record (DMR) data.
Strengths
- ISO 14971:2019, ISO 13485:2016, FDA QMSR / 21 CFR Part 820, EU MDR 2017/745, IVDR 2017/746, IEC 62366-1, IEC 62304, and FDA cybersecurity premarket guidance pre-mapped so one evidence item satisfies FDA, EU notified-body, and ISO 13485 audits
- Single-tenant deployment with customer-owned data residency, which matters for DHF and DMR retention required under 21 CFR 820.181 and for EU MDR Article 10(8) technical documentation retention
- 33-year operating history with federal customers (US Department of Defense, VA, DOJ per public press); long bench in regulated industries with FDA inspection exposure
- Vendor risk management module supports supplier qualification and supplier audit required under 21 CFR 820.50 and ISO 13485 section 7.4 purchasing controls, including critical-supplier risk classification
- Physical security assessment module supports IEC 81001-5-1 and FDA cybersecurity guidance physical-security controls for connected device manufacturing sites
- Survey-based assessment engine works for non-technical control owners; design engineers, regulatory affairs, and quality engineers can complete ISO 14971 hazard-analysis surveys without IT translation
- Published support tier ladder starting at 99 dollars per month Standard; rare in this category where seven of ten vendors gate pricing entirely
Weaknesses
- Not a purpose-built device eQMS at the depth that Greenlight Guru, MasterControl, Veeva Vault QualityOne, ETQ Reliance, Sparta TrackWise Digital, Qualio, or Pilgrim SmartSolve ship; RiskWatch runs the risk and assessment layer rather than a closed-loop Design Controls, CAPA, and change-control workflow tied to the DHF and DMR
- No native PLM, ALM, or design-tooling integration; Jama Connect, Polarion ALM, Codebeamer, PTC Windchill, and Siemens Teamcenter integrations are scoped per request rather than shipped pre-built
- Public pricing is partially opaque above Professional; Enterprise tier is quote-only because device-deployment topology and FDA inspection-readiness profile vary materially
- Brand recognition on G2 and Capterra for medical-device quality specifically lags Greenlight Guru, MasterControl, Veeva, Qualio, and Sparta; total third-party review volume in the device cohort sits below 100
- No native ISO 14971:2019 risk-matrix engine at the depth that Greenlight Guru ships; risk-matrix and risk-control documentation runs through the survey and evidence layer rather than a dedicated hazard-trace UI
- UI shows its operational heritage in places compared to newer SaaS entrants like Greenlight Guru and Qualio for digital-first device customers
Class II and Class III medical device manufacturers, IVD makers, and contract manufacturers running 3+ frameworks (FDA QMSR + ISO 13485 + EU MDR + ISO 14971) who want one tenant covering risk assessment, supplier qualification, and audit-evidence with single-tenant DHF data residency.
Single-product venture-stage device startups whose only need is a closed-loop Design Controls and DHF workflow; Greenlight Guru and Qualio fit that brief better as primary device-native eQMS tools.
Key features
- ISO 14971:2019 risk management process aligned (hazard identification, risk analysis, risk evaluation, risk control, residual risk, benefit-risk)
- ISO 13485:2016 medical-device QMS controls (now incorporated by reference into FDA QMSR)
- FDA QMSR / 21 CFR Part 820 aligned (effective February 2 2026)
- EU MDR 2017/745 + IVDR 2017/746 technical documentation library
- IEC 62366-1:2015 usability engineering process alignment
- IEC 62304:2006 + A1:2015 medical device software lifecycle library
- FDA cybersecurity premarket submissions content (October 2023 final guidance)
- Supplier qualification + supplier audit tracking aligned to 21 CFR 820.50 and ISO 13485 section 7.4
- Evidence vault with versioning and audit-ready export (FDA + EU notified-body inspection pack)
- Single-tenant deployment for DHF and DMR data residency
Integrations
25+ native. Notable: Microsoft Entra ID (SAML SSO), Okta, Microsoft 365 / SharePoint, Slack, Jira, Salesforce, Custom REST API.
Target size
50 to 50,000 employees · US · Canada · EU · UK · AU