Document Management for MedTech industry
Validated document control built for ISO13485, QSR, MDR, IVDR
Manage the entire document lifecycle—create, review, approve, release, and archive—in a single, compliant eQMS. MedQdoc delivers full traceability, version control, and audit-ready records for MedTech teams.
Document Management built for MedTech
Manage the entire document lifecycle—from creation and review to approval, release, and change control—inside a single, pre-validated environment. MedQdoc helps medical device teams comply with ISO 13485, ISO 14971, QSR, and EU MDR/IVDR while maintaining full traceability, secure access control, and audit-ready records.
- End-to-end document lifecycle with versioning, e-signatures (21 CFR Part 11), and automated review reminders
- Process-aware structure that links procedures, templates, and technical files
- Centralized template management for consistent, up-to-date documentation
- Audit trails and quality system records that are searchable and inspection-ready
Explore how MedQdoc streamlines documentation and accelerates compliance:
MDR QMS templates, Technical documentation templates, and our customer case study. Book a demo
Document Lifecycle Management
Control every stage of your document lifecycle — from creation and editing to review, approval, release, and archiving — within a validated, compliant environment. MedQdoc ensures every change is traceable, every approval is compliant, and every document remains audit-ready.
- Create and edit documents with version tracking
- Send documents for review and electronic approval (21 CFR Part 11 compliant)
- Publish approved versions and automatically archive outdated ones
Template Management
Ensure consistency, compliance, and efficiency across all your documentation with MedQdoc’s Template Management. Manage approved templates for SOPs, records, and technical documentation in a centralized, controlled environment. Every template is versioned, access-controlled, and ready for use within validated workflows.
- Centralized library for all approved document templates
- Automatic distribution of new template versions across the organization
- Ensure only current, validated templates are used in documentation
- Link templates directly to processes and document types for full traceability
Technical Documents
Organize and control all technical documentation required under MDR, IVDR, and ISO 13485. MedQdoc helps you manage product-related files, risk documentation, and design records in a structured and compliant way — ensuring everything is inspection-ready.
- Maintain Technical Files and Design History Files (DHF)
- Link risk management, usability, and product documentation
- Control versions and approvals to ensure regulatory compliance
Quality Management System Records
Keep all QMS records organized, controlled, and easily accessible in MedQdoc. Manage internal audits, management reviews, CAPA documentation, and other key quality records in one compliant and searchable location.
- Store and manage audit reports, management review protocols, and CAPA records
- Maintain traceability and version control across all QMS records
- Ensure quick access during inspections and regulatory audits
Document Audit Trails
Ensure complete transparency and compliance with MedQdoc’s automated document audit trails. Every action — from creation and modification to review, approval, and archiving — is securely logged with time stamps, user identification, and version details. This provides full traceability and supports compliance.
- Automatic logging of all document actions and user activities
- Full version tracking with detailed change history
- Secure, time-stamped, and user-verified audit records
“I have had the pleasure of performing multiple internal audits on two different companies both using the eQMS MedQdoc. This system is well designed, user-friendly and facilitates not just document control but also effective case management. MedQdoc gives a good overview of the Quality Management System and provides users with the relevant documentation and information as and when required. I wholeheartedly recommend this well-designed system.” Melanie Janbro, Quality Consultant, Vinga Medtech Q Consulting
Discover how MedQdoc simplifies document control.
Explore the Document Control page to discover key feature highlights, including version control, and real examples of how it works in practice.
Read moreDiscover how MedQdoc Case Management works.
Explore the Case Management page to discover detailed insights and real examples of CAPA, Nonconformity and other key quality processes.
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MedQdoc is used across the medical device industry
