Transform Your

Medical Device Development

Save Time, Reduce Errors and Ensure Compliance

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Solving Documentation Challenges

The Shift From PDFs To Integrated System

DocuMed Demo

Traditional methods of handling medical device documentation often involve cumbersome and error-prone processes. This includes managing paper documents, PDFs, and using network shared folders or services like Dropbox or SharePoint.

These methods can lead to:

  • Version control issues
  • Lack of real-time collaboration
  • Security vulnerabilities
  • Time-consuming navigation through scattered documents
  • Confusion in ensuring the latest version is in use

DocuMed offers a solution for managing medical device documentation, including change control and electronic signatures, making it easy for teams to collaborate effectively and securely.

Benefits of DocuMed

Enhanced Efficiency

Enhanced Efficiency

Streamline documentation processes and automate version control, ensuring the latest versions are always accessible.

Electronic Signatures

Electronic Signatures

Simplify approval processes with integrated electronic signature functionality, reducing delays and paperwork.

Cost Savings

Cost Savings

Reduce costs associated with paper-based documentation and minimize the need for physical storage space.

User-Friendly Interface

User-Friendly Interface

Enjoy an intuitive interface for easy navigation, reducing the learning curve for team members.

Traceability

Traceability and Auditability

Maintain a clear audit trail of document changes, approvals, and access for regulatory compliance.

Mobile Accessibility

Mobile Accessibility

Access documents and collaborate on the go with mobile-friendly features, ensuring productivity.

DocuMed Features

Features

  • Software validated according to FDA 21 CFR Part 11 and EU MDR requirements
  • Secure Cloud Storage with automatic nightly backups
  • Business partner logins for efficient cooperation
  • Electronic signatures for document approvals and workflow validations
  • Built with modern web framework Microsoft Blazor
  • Responsive UI supporting PCs, tablets, and mobile phones

Future Updates

  • Design Control Module with electronic linkages
  • Electronic Quality Management System (eQMS)
  • Lifecycle Management tools

Pricing Plans

DocuMed Essentials Plan

€250/month

Starting at 5 users (€50/user/month thereafter)

  • ✓ All DocuMed modules included
  • ✓ 2 Business Partner logins per user
  • ✓ 8 hours initial support
  • ✓ 2 hours monthly support
  • ✓ Continuous FDA-compliant validation
  • ✓ Nightly backups


Get Started

The DocuMed Essentials Plan offers a robust, entry-level package designed for businesses seeking reliable document management and compliance support. This plan includes access to all DocuMed modules, two business partner logins per user, and essential support with 8 hours of initial setup assistance and 2 hours of monthly ongoing support. With nightly backups and continuous FDA-compliant validation, this plan ensures your document management system remains secure and up-to-date without a high level of internal maintenance.

DocuMed DMS Plan

€1,000/month

Starting at 5 users (€150/user/m thereafter)

  • ✓ 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
Contact Us

The Full DMS Management Plan is designed for businesses that want to offload the entire document management process to our experts. With this plan, we handle all aspects of your DMS, including document creation, change orders, approvals guidance, and releases. Your dedicated DMS manager ensures seamless operation, compliance, and minimal internal effort. This plan is ideal for organizations that prefer to focus on their core operations while we manage their document control processes entirely.

DocuMed Premium Plan

Contact us for an offer

Tailored solutions for your QMS and DMS needs

  • ✓ All DMS Plan features included
  • ✓ Comprehensive SOP template library
  • ✓ Access to all QMS-related templates
  • ✓ Custom branding for QMS and DMS templates
  • ✓ QMS process support and management
  • ✓ Proactive compliance monitoring
  • ✓ Unlimited support and system handling
Contact Us

With the Premium DocuMed Plan, your team receives specialized, ongoing support that extends beyond basic system maintenance. This includes proactive assistance with QMS and DMS processes, such as document releases, due date tracking, and compliance monitoring, ensuring your team stays compliant with minimal internal effort. Our team guides users through each step of document approval and release workflows, with optional rebranding of SOP and QMS templates to reflect your organization's branding standards. By streamlining quality management tasks, this plan is designed to offset the workload of a junior quality assurance professional, enabling your team to focus on core business objectives while maintaining a high level of compliance and operational efficiency.

About Us

About DocuMed

We are company based in Hradec Králové, Czech Republic - a city hosting two major medical device companies. With 24 years of experience in medical device systems implementation, our team brings unparalleled expertise to the field.

Our Focus

  • Medical device development processes
  • Quality assurance and Quality control
  • Regulatory compliance
  • Systems integration

Contact Us

We're always ready to discuss how our expertise can benefit your medical device projects.

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