ISO 13485 – Quality Management System (QMS)

QMS Compliance, Consulting & Implementation

At QMLogic, we specialize in providing expert ISO 13485 consulting and Quality Management System (QMS) implementation for medical device manufacturers. Whether you are building a QMS from scratch or enhancing an existing system, our services ensure complete compliance with ISO 13485 requirements and EU MDR 2017/745 standards while optimizing your processes for efficiency and scalability.

Why is ISO 13485 Quality Management System Essential for Medical Device Companies

ISO 13485 is the internationally recognized standard for medical device Quality Management Systems. Implementing an ISO 13485-compliant QMS is crucial for:

Meeting regulatory requirements for CE certification and FDA approval
Managing product risks and ensuring patient safety
Streamlining processes for consistent product quality
Enabling market access in Europe, the U.S., and other global markets

A robust ISO Quality Management System also integrates seamlessly with regulatory standards such as IEC 62304 (Software Life Cycle), ISO 14971 (Risk Management), and IEC 81001-5-1 (Cybersecurity).

Our ISO 13485 Consulting & QMS Compliance Services

ISO 13485 QMS Implementation Consulting

We offer full-scope ISO 13485 implementation consulting services, including:

Designing and documenting new Quality Management Systems (QMS)
ISO 13485 certification preparation and audit readiness
Corrective and Preventive Actions (CAPA) management
Internal QMS audits and gap assessments
Tailored quality system processes based on company size and product risk class

Digital Quality Management System Software Integration

As part of our QMS consulting services, we also specialize in QMS digitalization using modern tools:

Jira for CAPAs, change management or design controls
Confluence or Sharepoint for QMS documentation control
Microsoft Power Platform and AI-based solutions for automated workflows

ISO 13485 Requirements and Compliance

Our consultants ensure full alignment with ISO 13485 requirements, including:

Risk-based process approach
Documents and records control
Supplier and purchasing controls
Design control and product realization

We help you implement these processes efficiently to ensure ISO 13485 compliance and certification.

Benefits of Working with QMLogic ISO 13485 Consultants

We have built multiple quality management systems from scratch, successfully passed many external audits, and completed numerous CE certifications.

We build QMS processes that primarily work for your organization; compliance is essential, but the internal processes must work for the team first.

We are not afraid of making deep cuts into non-functioning systems to bring quality management back on track.

We will build modern, digitized and understandable Quality Management Systems.

Proven track record of successful ISO 13485 QMS implementations
Expertise in CE certification and external audit preparation
Practical, risk-based QMS tailored to your company’s structure
IEC 62304 and ISO 14971 integration for medical device software
QMS software automation for scalable, efficient quality systems

ISO 13485 Certification Support

Preparation for ISO 13485 Certification Audits

We provide:

Pre-certification gap analysis and internal audits
Documentation review and updates
Nonconformity remediation and process improvements

ISO 13485 Certification for Medical Devices

Our services support companies developing:

Medical device combined products
Standalone Software as a Medical Device (SaMD/MDSW)
Cloud-based SaaS medical device solutions
Software-based in-vitro diagnostic medical devices

Connected Services to Enhance Your ISO 13485 QMS Software

Regulatory Consulting for SaMD/MDSW – Ensure complete MDR, FDA, IEC 62304, ISO 14971, and cybersecurity compliance.

QMS Digitalization & Automation – Implement ISO 13485-compliant processes using Jira, Confluence, and SharePoint.