--- title: DocuMed — document control and expert support for medical device teams description: Controlled documents, change workflows and electronic signatures, with expert-led agentic services working on records held in DocuMed. --- [Website](index.html) · [Software & services](index.html#offers) · [Pricing](index.html#pricing) · [Contact](index.html#contact) · [Log in](https://access.documed.app) For medical device teams # Document control and expert support for medical device teams. Keep your documents controlled in DocuMed. Let our experts use AI agents to review those records, prepare draft work, and identify what needs attention — with your people in control of decisions and approvals. [Discuss your project](index.html#contact) [Explore the software](index.html#software) ![DocuMed — validated document control for medical device companies](assets/intro.png) A look inside DocuMed 00:41 Watch the 41-second overview Play with sound · English captions Read the video transcript This is DocuMed — validated document control for medical device companies. After login, you see your activity and your company. Every document, with versions and states. Nothing hides in email. Approvals wait in one inbox. Nothing gets lost. Each document carries its audit trail — who did what, and when. Every signature is recorded. And full-text search finds anything in seconds. Contact us at info@documed.app. 01 / Software & services ## A controlled foundation. Expert help to move forward. Use DocuMed to manage the records. Work with our experts when you need help making sense of them and preparing the next step. DocuMed software ### Your records, under control. Bring documents, revisions, change workflows, electronic signatures and traceability into one cloud system. Documents and versions Keep revision history and clear document states, from new work to released and superseded records. Change workflows and signatures Route changes through assigned people, with electronic signatures recorded against the approval workflow. Access and traceability Use role and item permissions to control access. Audit records capture significant changes, who made them and when. [View software plans](index.html#pricing) Expert-led agentic services ### Your next step, well prepared. Our experts work with your customer data held in DocuMed to review evidence, prepare drafts and identify what needs attention. #### What does “agentic” mean? AI agents carry out a sequence of tasks on agreed records, guided and checked by our experts. These are expert services working with your records. Your people review the outputs and decide what to approve. Agentic work is scoped and quoted separately for your project. [Explore expert services](index.html#services) Planned software extensions Design Control module with electronic linkages, electronic Quality Management System (eQMS), and lifecycle management tools. These remain planned extensions. 02 / Expert services ## Useful work. Grounded in your records. Start with an agreed question and the relevant records in DocuMed. The examples below illustrate the draft outputs we can prepare for review. ### QMS management support We help manage your QMS: review records, identify gaps, prepare updates, and track actions. Your designated people retain decisions, approvals, signatures, and release authority. **Illustrative deliverable** A gap review, draft updates and an action list for your responsible people to review. ### Submission preparation Extract and organize supporting evidence from records in DocuMed into traceable draft submission material for expert review. The scope is agreed for each project; acceptance or clearance is not promised. **Illustrative deliverable** An evidence index and source-linked draft material for your submission team. ### Data extraction and review Turn information in controlled records into structured tables and source-linked summaries. Identify missing or conflicting information for people to resolve. **Illustrative deliverable** A structured evidence table with references, open questions and inconsistencies. ### FMEA and risk-analysis support Prepare and cross-check draft failure mode and effects analyses (FMEA) and other risk analyses against available evidence. Responsible experts assess the risks and approve conclusions; scores and engineering facts must come from evidence and expert judgment. **Illustrative deliverable** A cross-checked draft analysis with evidence references and gaps to resolve. Planned extension ### Design-development documentation A planned extension: organizing requirements, evidence and draft development records with human review. **Illustrative deliverable** Planned output: a connected set of draft development records for expert review. 03 / Working together ## A clear path. People at every decision. From agreed records to reviewed work, with your designated people in control. ### Agree the records Define the question, scope and records held in DocuMed that our experts will work with. ### Prepare and check drafts Our experts guide the agents, check the outputs against the sources, and identify gaps. ### Human review and approval Your designated people assess the work and retain decisions, approvals, signatures and release authority. ### Controlled records Your authorized people take accepted work through the appropriate DocuMed workflow. A draft is not automatically an approved record. AI-generated drafts do not sign, approve or release themselves. Your designated people retain that authority. Model processing ### Agreed for your project. Model processing through Amazon Bedrock or Microsoft Azure is available on request, with configuration agreed for your project. 04 / Plans & pricing ## Choose the support your team needs. From software and setup support to ongoing document and quality management. ### DocuMed Essentials Plan **€250** /month Starting at 5 users. €50 per extra user/month. - All DocuMed modules included - 2 Business Partner logins per user - 8 hours initial support - 2 hours monthly support - Continuous FDA-compliant validation - Nightly backups Document management with initial setup assistance and ongoing support. [Discuss Essentials](index.html#contact) ### DocuMed DMS Plan **€1,000** /month Starting at 5 users. €150 per extra user/month. - All DocuMed Essentials Plan features included - Full document management on the customer's behalf - Comprehensive change order management - Unlimited support and system handling - Comprehensive system training - Assistance with DMS-related project management Support for document creation, change orders, approval guidance and releases, with a dedicated DMS manager. [Discuss DMS](index.html#contact) ### Agentic services **Contact us** for an offer Scoped and quoted for your project. Expert-led work with your records in DocuMed. Your designated people retain decisions, approvals, signatures and release authority. [Contact us](index.html#contact) ### QMS Template Package **Contact us** for an offer One-time template purchase. - Comprehensive SOP template library - Access to all QMS-related templates - Custom branding for QMS and DMS templates Buy the QMS templates once, then manage the documents through the DocuMed DMS Plan. [Contact us](index.html#contact) 05 / About DocuMed ## Experience with the work behind the documents. **24 years** of experience in medical device systems implementation. Based in Hradec Králové, Czech Republic. Our work connects medical device development processes, quality assurance and quality control, regulatory compliance, and systems integration. We bring that experience to both DocuMed software and the expert services built around your records. Let’s talk ## What would help your team move forward? Ask for a software demonstration or tell us about the records and work you need help with. We’ll discuss the scope and the next step. [info@documed.app](mailto:info@documed.app) [Already using DocuMed? Log in](https://access.documed.app) [Watch the overview video](assets/hero_voiceover.mp4) · [English captions](assets/hero_voiceover.vtt) © 2026 DocuMed · Hradec Králové, Czech Republic