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