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eQMS for Medical Devices

Struggling withpaper chaos and manual QMS workflows?preparing for ISO 13485 & MDR audits?to scale documentation, CAPAs, and design controls?We help you with a validated, ready‑to‑use eQMS built for Medical Devices.

We implement a modern, scalable eQMS tailored for small companies, SaMD innovators, and MedTech teams who need a fast, affordable, compliant foundation. Get only what you need—without the complexity of enterprise systems.

Our Expertise in eQMS for Medical Devices

eQMS Setup

We implement an eQMS tailored for SaMD and MedTech teams, aligned with ISO 13485, MDR, and FDA requirements—without adding unnecessary complexity.

End‑to‑end process mapping and lifecycle
Pre‑validated templates
Tailored process configuration
Core documentation starter pack

Audit‑Ready Documentation

Prepare for ISO 13485 audits, regulatory audits with a documentation framework built for clarity, compliance, and consistency.

Internal audit preparation
Audit trail configuration

CAPA & Change Management

Digitize CAPA and change control in a way that increases traceability and reduces administrative burden across your quality system.

Configured CAPA workflows
Streamlined change control process
Quality review checkpoints

Training & Competence

Ensure your team stays trained, compliant, and inspection‑ready with automated training assignments and competence tracking.

Training matrix setup
Training confirmation workflows
Competence dashboards
Integrated training records

Supplier & Document Control

Centralize suppliers and documentation in controlled workflows that support global regulatory expectations and operational efficiency.

Document control configuration
Supplier qualification workflows
Versioning & approval processes
KPI dashboards

Seamless Jira–QMS Integration

Extend your existing development workflows with a connected, compliant QMS—ensuring full traceability without introducing new tools or complexity.

Bidirectional Jira–QMS linking
Integration setup to eliminate system‑switching
Reduced licensing through existing tool use

Regulatory‑Ready Compliance Framework

A QMS built to meet global medical device regulations from day one, with controlled documentation, secure approvals, and complete traceability.

ISO 13485 & FDA‑compliant document control
Version & change history tracking
Role‑based access and permissions
Audit‑ready quality records

Enhanced Team Collaboration

Connect quality, regulatory, and development teams in one integrated workspace that improves transparency and accelerates product development.

Unified cross‑functional workflows
Full lifecycle visibility
Secure access for distributed teams
QMS integrated into daily operations

Trusted by Leading Laboratories

"Our collaboration with wega enabled us to easily implement and validate a very nice, user-friendly and affordable electronic quality management system compliant to ISO13485 and accordingly close a corresponding opened non-conformity. wega also consulted us on how to best document our Software Development in accordance with IEC62304 by leveraging Jira and maintain our technical documentation more easily.
wega also thankfully joined our ISO13485 surveillance audit in the absence of our QARA which was of great help to defend the proper setup of the QMS."

C. Morel, CEO, Axomove

“Our collaboration with wega Informatik enabled us to convert early stage academic documentation into a comprehensive, MDR compliant technical dossier. Their structured V&V plan and thorough testing supplied the Notified Body with the requisite evidence, facilitating CE marking for both PC and VR implementations. The team's expertise in ISO, IEC and ISTQB standards supported our regulatory approvals. wega also delivered a comprehensive workshop on complex regulatory requirements for AI enabled medical devices. Their practical guidance on standards, risk management, and FDA aligned validation accelerated our internal readiness and informed our strategic decisions.”

Charly Leprince, QARA Manager SaMD at Specto Medical AG

"We worked with wega to implement and customize our ticketing system. They delivered a solution that perfectly met our needs. Their comprehensive training empowered our team to manage the system independently going forward. We look forward to continuing this partnership on future projects as our business grows. "

K. Müsch, QARA, 2025

Why Our eQMS is the Perfect Fit for Small MedTech & SaMD Teams

Small companies need speed, simplicity, and compliance—without enterprise overhead. wega’s eQMS provides a pre‑validated, modular quality system built exactly for MedTech startups, especially those developing Software as a Medical Device. We configure your QMS based on your maturity, your regulatory pathway, and your product lifecycle.

You get only what you need, nothing you don’t. And every module is designed to scale as your company grows.

Download our service flyer

Tools We Are Expert in

Ready to build an audit‑ready, scalable eQMS without the complexity of enterprise tools?

Let’s design the system that fits your MedTech or SaMD roadmap.

Knowledge Base

Article

Remediation of Medical Device Design History File

This white paper addresses the issue of DHF debt and how to resolve this debt through DHF remediation. It also addresses the reasons for DHF debt and best practices for effective remediation.

Article

Why You Should Prefer Modern Tools to Traditional Methods for Creating CSV Documents

This article looks at the benefits and challenges of introducing modern documentation tools for CSV and highlights their role in simplifying processes, reducing errors and improving traceability...

Contact us

Christophe

Managing Director
Board of Directors
CSV & QA