> Digital quality management for medical device manufacturers. ISO 13485, MDR, FDA 21 CFR Part 820. DHF/DMR management, CAPA, Technical File. Baseline from €89/month; credit packages priced separately.

Source: [https://docxpert.io/en/use-cases/medtech](https://docxpert.io/en/use-cases/medtech)

ISO 13485 & MDR

# QMS for Medical Device Manufacturers

ISO 13485 & EU MDR Compliant

Digital quality management system specifically for medical device manufacturers. DHF/DMR management, CAPA, technical files and complete audit trails for approvals and audits.

[View All Features](https://docxpert.io/en/features)

## Challenges in Medical Device Industry

MDR Requirements

EU MDR requires comprehensive technical documentation, post-market surveillance and clinical evaluation. Paper-based systems are no longer practical.

Design History File (DHF)

Complete documentation of the entire development process. Every change must be traceable – from design idea to production.

CAPA Management

Corrective and Preventive Actions must be systematically recorded, root cause analyzed and effectiveness proven. FDA and Notified Bodies scrutinize closely.

Audit Preparation

Before each audit: weeks of searching for documents, evidence and signatures. Auditor still finds gaps.

Supplier Management

ISO 13485 requires supplier evaluation, audits and approvals. Critical components must be completely traceable.

Change Control

Every change to product or process must be documented, evaluated and approved. Impact analysis on existing approvals.

## The docxpert.io Solution for Medical Devices

4 Months

To ISO 13485 Certification

Average time from start to certificate with docxpert.io

60%

Faster Audit Preparation

All evidence available at the push of a button

100%

Audit Trail Coverage

Complete traceability of all changes

## Key Features for Medical Devices

Design History File (DHF) Management

Structured storage of all design documents: Requirements, Design Inputs/Outputs, Verification, Validation. Automatic linking between documents.

[Mehr erfahren](https://docxpert.io/en/features/document-management)

CAPA Management

ISO-compliant CAPA management with Root Cause Analysis (5-Why, Ishikawa), action tracking and effectiveness verification. AI support for root cause analysis.

[Mehr erfahren](https://docxpert.io/en/features/capa-management)

Technical File & Regulatory Submissions

Central management of technical documentation for MDR/IVDR. Automatic generation of submission packages for Notified Bodies.

Supplier Management

Supplier evaluation, audit planning and approvals. Critical components with complete traceability to products and batches.

Risk Management (ISO 14971)

Risk analysis, FMEA and risk-benefit assessment. Automatic linking of risks to mitigations and verifications.

Post-Market Surveillance

Recording of vigilance reports, complaint handling and trend analysis. Automatic escalation for critical events.

## ISO 13485:2016 Requirements Covered

docxpert.io fulfills all documentation-related requirements of ISO 13485:2016

4.2.4 Control of Records

4.2.5 Control of Documents

7.3 Design & Development

7.4 Purchasing & Supplier Management

7.5.6 Validation of Processes

8.2.1 Feedback & Complaint Handling

8.2.2 Complaint Handling

8.3 Control of Nonconforming Product

8.5.2 Corrective Action (CAPA)

8.5.3 Preventive Action

## Regulatory Compliance

EU MDR/IVDR

Complete technical documentation according to Annex II/III

-   Clinical Evaluation Reports
-   Post-Market Surveillance Plan
-   PMCF & Vigilance
-   Technical File Management

FDA 21 CFR Part 820

Quality System Regulation for US market

-   Design Controls (DHF/DMR)
-   CAPA System
-   Complaint Files
-   Supplier Controls

ISO 14971 Risk Management

Risk management for medical devices

-   Risk Analysis & FMEA
-   Risk-Benefit Assessment
-   Post-Production Monitoring
-   Risk Management File

## Start Your ISO 13485 Certification

No credit card required. 14 days free trial. Personal onboarding support for medical device manufacturers included.

[Book Demo](https://docxpert.io/en/features)

## Other Industries & Use Cases

[ISO 9001 for SMEs Digital QMS for crafts, small manufacturing and services](https://docxpert.io/en/use-cases/iso-9001-sme)[Automotive IATF 16949 Automotive suppliers with PPAP, 8D Reports and APQP Management](https://docxpert.io/en/use-cases/automotive)[Pharma & Life Sciences GxP GxP-compliant documentation with 21 CFR Part 11 and EU GMP Annex 11](https://docxpert.io/en/use-cases/pharma)