# PreQMS Software Pricing, Alternatives & More 2026 | Capterra > With the help of Capterra, learn about PreQMS Software - reviews, pricing plans, popular comparisons to other Quality Management products and more. Source: https://www.capterra.com/p/10045033/PreQMS --- # PreQMS Software Review 2026: Features, Reviews, Integrations, Pros & Cons Last updated on June 16, 2026 Provider data verified by our Software Research team, and reviews moderated by our Reviews Verification team. [Description](#description)[Use cases](#use-cases)[Features](#features)[Pricing](#pricing)[Support](#support) PreQMS ## What is PreQMS? PreQMS is a requirements management and technical documentation platform built specifically for medical device companies pursuing FDA 510(k) clearance, IEC 62304 compliance, and ISO 13485 certification. Unlike general-purpose QMS tools or spreadsheets, PreQMS structures your entire technical documentation set — software requirements (SRS), test cases (SSTC), test procedures (SSTP), risk analysis (ISO 14971), use case specifications, fault tree analysis (FTA), cybersecurity documentation (FDA 2023 guidance), and design specifications — in a single platform with built-in cross-module traceability. PreQMS helps medical device teams: • Eliminate spreadsheet chaos. Replace disconnected Word docs and Excel sheets with structured, typed modules where every requirement, test case, and risk item has a permanent ID and traceable links. • Generate documentation with AI. Create test cases from requirements, generate use case specifications, review SRS documents for completeness and testabi ## What is PreQMS used for? [Quality Management](https://www.capterra.com/quality-management-software/) Overall rating Based on 0 user reviews Reviews sentiment Positive \- Neutral \- Negative \- Starting price $199 Per User, Per Month Free trial available Includes Free Version Capterra Shortlist charts the highest-rated and most popular products... Our "Best of" badge program showcases products with the highest ratings... Our "Best of" badge program showcases products with the highest ratings... Do you work for PreQMS?[Manage this product listing](https://digitalmarkets.gartner.com/get-listed/claim-bx?url=https://preqms.com/&name=PreQMS) ## Features Features with the highest number of reviews are displayed first. Those that have no reviews appear next, sorted alphabetically. Audit Management Plan, schedule, and execute organization's accounts and assets to ensure compliance with policies and laws Compliance Management Track and manage adherence to policies for any service, product, process, or supplier Document Coding & Control Management and control of the creation, approval, and distribution of documents and processes to ensure they meet industry regulations Document Management Store, manage, and track all electronic documents in a centralized location Electronic Signature Digitally sign online documents Generative AI Use AI to generate content in the form of text, images, videos, etc. PreQMS 8 features Plan, schedule, and execute organization's accounts and assets to ensure compliance with policies and laws Track and manage adherence to policies for any service, product, process, or supplier Management and control of the creation, approval, and distribution of documents and processes to ensure they meet industry regulations Store, manage, and track all electronic documents in a centralized location Digitally sign online documents Use AI to generate content in the form of text, images, videos, etc. Initiate collection and analysis of known risks Process of identifying, evaluating, mitigating, addressing and reporting on potential risks or uncertainties Get Advice We can help you find the software with the features you need. ## Pricing Free Trial Free Version Software (Platform) $199.00 Per User,Per Month It includes: - All document types (SRS, SSTC, SSTP, FTA) - AI requirement generation and review - Formal review and sign-off workflow - Traceability matrix and baselines - Submission readiness dashboard Software + Services (Platform + Guided Setup) $199.00 Other,One Time It includes: - Everything in Tier 1 - Expert workspace setup and configuration - Import and structure existing documents - First AI review pass with expert commentary - Gap analysis against IEC 62304 and FDA expectations - 30-day post-setup support Fully Managed (Managed Documentation) $15,000 Other,One Time It includes: - Full SRS, SSTC, SSTP authoring - Risk management (ISO 14971) - Cybersecurity (AAMI TIR 57) - HIPAA and GDPR auditing - Complete traceability and Design History File - Investor due diligence reports Connect with a Capterra advisor for a free 15-minute consultation Get a personalized software list aligned to your business needs with guidance from our expert advisors. Our team has helped 1 million+ businesses like yours find options that fit their needs. ## Support, customer service and training options Support - Email/Help Desk - FAQs/Forum - Knowledge Base - Phone Support - 24/7 (Live rep) - Chat Training - In Person - Live Online - Webinars - Documentation - Videos Deployment - Web - Android - iPhone/iPad Typical users - Freelancers - Small businesses - Mid size businesses - Enterprises ## Top-rated software of 2026 ### Fill out the form and we'll send a list of the top-rated software based on real user reviews directly to your inbox.