Class I Medical Device Manufacturers Need an established QMS Under the New MDR
Mastering Document Control: How MedQdoc guides you from draft to archive
When it comes to building a compliant Quality Management System (QMS), your document control process is at the heart of it all.
Policies, procedures, work instructions, standard operating procedures (SOPs), and technical documentation all need to be up-to-date, version-controlled, and audit-ready.
But too often, document management systems become a source of frustration:
Endless email threads to get a document review done Multiple versions stored in different folders, no single source of truth Stress before audits trying to prove who approved which version With MedQdoc’s electronic document management system (eQMS), we set out to fix that.
Our platform manages the entire document lifecycle — from the very first draft to final archiving — in a single, validated, ISO 13485- and 21 CFR Part 11-compliant solution.
Step 1: Draft – Where It All Begins?
Every document starts as a Draft — and in MedQdoc, that’s where control begins.
Only the creator can edit a draft, but with one click, you can invite other users as collaborators. Together, you can:
- Create and co-author Word, Excel, or PDF-form documents directly in MedQdoc
- Use track changes to capture edits for regulatory compliance
- Leave comments and reply inline — no messy email chains
Each document is automatically assigned an ID number and starts as Version 1.0, ensuring you are always working with a traceable, audit-ready record.
And because context matters, you can:
- Tag your document with predefined categories such as Risk Management File, Technical Documentation, Usability File
- Link it to one or more products (perfect for Risk Management Reports, Periodic Safety Update Reports (PSURs))
- Reference relevant standards and regulations (ISO 13485, MDR/IVDR, 21 CFR Part 820, ISO 27001)
MDR Article 10 states all these general obligations of medical device manufacturers and more specific the section 9 spells out a clear list of what the quality management system (QMS) shall contain.
Step 2: Review – Get everyone on the same page
When your draft is ready for feedback, send it into Review mode.
- Notify reviewers automatically
- Collect feedback and comments directly in the system
- Track progress and see who has completed their review
- Keep everyone on the same version and avoid version chaos
This step helps you comply with document control requirements and speeds up your review cycles dramatically.
Step 3: Approval – Secure, Digital Signatures
Once the document is finalized, MedQdoc ensures approval is fully compliant:
- Electronic signatures that meet FDA 21 CFR Part 11 requirements
- Time-stamped, user-attributed approvals for a perfect audit trail
- Role-based permissions so only authorized users can sign off
- Change management
- Risk management
- Complaint handling and vigilance reporting
- Supplier management
This guarantees your team always works from the latest, approved version.
Step 4: Published – Distribute with Confidence
Approved documents are instantly available in Published status:
- Users see only the documents relevant to them (role-based access control)
- Reading receipts track who has read and acknowledged the content
- Dashboards and reports give you real-time insights and make audit preparation easy
This keeps your QMS organized, compliant, and inspection-ready.
Step 5: Archived – Keep Your QMS Clean
When a document is replaced or marked as obsolete, it moves into Archived status:
- Automatic archiving happens when a new version is published
- Archived versions remain searchable and traceable for audits and inspections
- Review version history anytime and even restore information if needed
This keeps your QMS organized, compliant, and inspection-ready.
Why this matters?
A controlled document lifecycle is not just best practice — it’s a regulatory requirement under ISO 13485, MDR/IVDR, and FDA QSR (21 CFR Part 820)
MedQdoc helps you:
- Eliminate paper-based processes and manual version control
- Maintain full traceability and compliance for every document
- Save time and reduce stress before audits and inspections
Ready to take control of your Documents?
MedQdoc makes document control simple, compliant, and collaborative — so you can focus on building better products, not chasing document version.
- Book a demo today and see how MedQdoc can transform your QMS document management process!
MedQdoc is used across the medical device industry
