Tools in MedQdoc – Your Complete Document Ecosystem for Medtech Compliance

Word-Compatible DOCX

MedQdoc supports DOCX (Microsoft Word-compatible) as a first-class document format. This makes it easy for your team to work with familiar tools while staying inside a controlled eQMS environment.

Key benefits of DOCX in MedQdoc:

• Create and upload DOCX documents for SOPs, work instructions, risk reports and more using Microsoft Word or equivalent editors.
• Collaborate with reviewers using comments and clear review workflows directly connected to your QMS processes.
• Lock approved documents so only the published version is used in audits and daily operations.
• Track every change with automatic version control and a complete audit trail.

With MedQdoc, you keep your existing way of writing documents in Word, but add structure, approval control and regulatory compliance on top – aligned with ISO 13485, MDR and FDA expectations.

Excel-Compatible XLSX

Spreadsheets are essential in MedTech for risk management, traceability, design controls and planning. MedQdoc fully supports XLSX (Microsoft Excel-compatible) so you can use Excel where it makes the most sense – without losing control.

Typical XLSX use cases in MedQdoc:

• Risk Management matrices and risk evaluation tables maintained in Excel.
• Design input/output traceability tables connected to your device files.
• DHF and DMR indexes that reference all relevant documentation.
• Planning sheets and checklists linked to quality processes and records.

Every XLSX file in MedQdoc is versioned, reviewed and approved just like any other controlled document, ensuring that your “living spreadsheets” still meet MDR, ISO 13485 and FDA QSR/QMSR expectations.

PDF Forms – The Standard for Checklist Documents

PDF forms are the preferred format for finalized and approved checklist documentation. MedQdoc supports fully fillable PDF forms that can be used for batch records, production protocols, inspection checklists, and supplier assessment documentation.

With PDFs in MedQdoc you can:

• Store final, approved versions of procedures, reports, checklists, and records as PDF.
• Use fillable PDF forms for inspections, audits, batch documentation, and other GxP activities.
• Ensure that all PDF content is traceable, versioned, and linked to the correct process, product, or regulatory file.

Once a PDF is approved and published in MedQdoc, it becomes part of your controlled QMS documentation and is always ready for internal and external audits, whether under EU MDR, ISO 13485 or FDA QSR/QMSR requirements.

Layouts – Built-in Visual Process

MedQdoc includes integrated Draw.io (diagrams.net) functionality, allowing you to create and manage diagrams directly in the platform.

Typical Draw.io usage in MedQdoc:

• Process flowcharts for QMS and production, aligned with your SOPs.
• Risk management diagrams and decision trees for devices and processes.
• System architecture diagrams for software and hardware medical devices.
• SIPOC and workflow diagrams for critical quality and regulatory processes.
• Streamlined stepwise workflow.

Each diagram is stored, versioned, and approved like any other document type. This means your visual process descriptions and risk diagrams are always aligned with your current QMS and technical documentation – supporting both EU and FDA audits.This creates full traceability from idea to compliant documentation.

Images and JPG – Visual Evidence and Design Support

Visuals are a critical part of MedTech documentation. MedQdoc lets you upload JPG and other common image formats so you can connect visual evidence directly to your QMS records.

Examples of how images are used in MedQdoc:

• Device design images and screenshots used in DHF and design reviews.
• Photos from inspections, tests or complaint investigations.
• Labeling, packaging and UI/UX screenshots for usability and regulatory review.
• Diagrams and sketches exported as images for quick visual reference.

By attaching images to CAPA cases, complaints, risk files or technical documentation, you keep all evidence in one structured, compliant system – supporting both MDR/IVDR and FDA expectations for traceability.

One Controlled Lifecycle for All Formats

The real strength of MedQdoc is that all these formats – Word-compatible DOCX, Excel-compatible XLSX, PDF, PDF forms, images and diagrams – follow the same controlled lifecycle.

• Draft → Review → Approval → Published.
• Automatic version control and complete audit trails.
• Only the latest approved version is visible as the official document.

This unified approach makes it easier for your team to stay compliant and reduces the risk of outdated documents being used in daily operations, whether you are preparing for MDR audits, ISO 13485 certification or FDA inspections.

To see how this works in real life, you can read how one MedTech company used MedQdoc to successfully pass ISO 13485 audits: MedQdoc eQMS Case Study – Inossia.