DocuMed

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 Explore the software
A look inside DocuMed00:41
Watch the 41-second overviewPlay 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 [email protected].

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Keep revision history and clear document states, from new work to released and superseded records.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

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
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 deliverableA 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 deliverableAn 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 deliverableA 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 deliverableA 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 deliverablePlanned 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.

  1. Agree the records

    Define the question, scope and records held in DocuMed that our experts will work with.

  2. Prepare and check drafts

    Our experts guide the agents, check the outputs against the sources, and identify gaps.

  3. Human review and approval

    Your designated people assess the work and retain decisions, approvals, signatures and release authority.

  4. 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.

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

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

Agentic services

Contact usfor 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

QMS Template Package

Contact usfor 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

05 / About DocuMed

Experience with the work
behind the documents.

24 yearsof 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.

Already using DocuMed? Log in