ISO 13485 Consulting Services for Your QMS
QMS Compliance, Consulting & Implementation
At QMLogic, we specialize in providing practical 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 full compliance with ISO 13485 and FDA Quality Management System Regulation (QMSR).
We shape your processes into a clear, efficient, and scalable system that supports everyday operations.
Our ISO 13485 & QMSR Compliance Services
We tailor our services to your current situation and goals. We support clients through:
Building QMS from the ground up
Complete design and implementation of a compliant system aligned with ISO 13485 and FDA QMSR requirements.
Gap analysis and process optimization
Identification of weak points in existing QMS and practical steps to close them effectively.
Integration with other regulatory requirements
Seamless connection between your QMS and post-market surveillance, vigilance, and risk management processes.
CAPA Remediation projects
Support in addressing findings from audits or inspections and bringing your QMS or documentation back to full compliance.
Digital transformation of QMS
Helping you transition to digital platforms that make your system faster, leaner, and easier to maintain.
Your Partner in Creating a Functional QMS
We build ISO 13485-compliant QMS systems for medical device manufacturers who want more than consulting reports.
We deliver functional systems ready for use.
Connecting Standards Into One Coherent System
Our approach is based on building real, working system that meet the requirements of ISO 13485 and Quality System Regulation, connected with other related international standards that support your regulatory compliance and business performance.
From Design Controls to Post-Market - One Integrated Flow
We will help you design, implement, and integrate every component of the quality management system; from document control and design controls to risk management and post-market activities.
Practical QMS Built Around Your Organization
We work closely with your team to create a quality system that is structured, digital, and aligned with your goals.
Our approach combines regulatory precision with operational practicality.
- Full ISO 13485 and QMSR implementation for medical device companies
- Integration of IEC 62304, ISO 14971, IEC 81001-5-1, and ISO 27001
- Design of processes that link quality, design, risk, and cybersecurity
- Transition of QMS into a digital, interactive environment
- Delivery of working solutions ready for audits and daily use
Your Team for Building an Effective, Living QMS
For us, a quality management system is a living framework that grows and evolves with your organization.
We don’t stop once the procedures are written. Implementation for us means ensuring that the system truly works in practice, connects people, and drives decisions. And this is also one of the first things auditors notice: whether your QMS supports real operations and decisions.
A functional QMS doesn’t exist in folders – it is lived by your people.
An effective QMS is one your people understand, use, and trust.
We make QMS implementation tangible. It’s not only about defining processes, it’s about embedding them into daily work so they remain functional and sustainable. Together, we turn requirements into a system that your people use naturally and confidently.
- Define realistic and scalable processes
- Assign clear responsibilities and ownership
- Integrate workflows with existing tools
Auditors consistently check if processes documented, but more importantly, followed; these steps make sure yours are.
ISO 13485 Certification Support
Whether you are getting ready for an ISO 13485 certification audit conducted by a notified body, preparing for an FDA inspection, or acting as a supplier being audited by your partners, we support you through every step of the process.
We provide a full spectrum of ISO 13485 and QMSR audit services designed to match your specific situation and goals.
We help you prepare for certification by ensuring that your quality management system is complete, compliant, and ready to demonstrate conformity during the audit.
We provide:
- Pre-certification gap analysis and internal audits
- Documentation review and updates
- Nonconformity remediation and process improvements
Digital Quality Management System Software Integration
From Paper to Digital Quality Management Reality
We understand that a modern quality management system must be digital, accessible, and seamlessly connected with your organization’s daily operations.
Every QMS we implement is designed to function within your environment – practical and aligned with how your teams actually work.
QMS Platforms That Fit Your Organization
We specialize in building ISO 13485-compliant systems on SharePoint and Microsoft 365, as well as on Confluence and Jira platforms.
Based on your needs, we integrate additional tools for training management, feedback collection, complaint handling, or clinical affairs activities.
A Living, Digital QMS Environment
Your quality management system will not remain a paper-based concept. It will become a fully digitized, interactive environment, compliant with ISO 13485 and QMSR, and naturally embedded into your organization’s everyday processes.
AI-Driven Quality Management
Our QMS implementations support a broad spectrum of AI-based features and capabilities, enabling intelligent document control, quality monitoring, and data-driven process improvement.
Benefits of Working with QMLogic ISO 13485 Consultants
We have built multiple quality management systems, passed numerous external audits, and supported CE certifications in compliance with the MDR.
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
QMS software automation for scalable, efficient quality systems
Questions & Answers
Any medical device developer or manufacturer is required to establish and maintain a quality management system within their organization.
While the law does not always explicitly demand certification to ISO 13485, this standard is internationally recognized and accepted under multiple regulatory frameworks, including EU MDR, FDA’s Quality Management System Regulation (QMSR), and MDSAP.
Testimonials | Expertise in ISO 13485
Vaclav did support our journey to become ISO 13485 certified with relentless work put into great processes, great communication and detailed and to the point conversations with the teams, individual members - but also our external auditors. He was of great support to move our QMS to the next level. He was the key person behind the move away from paper / scan based documents towards a digital setup.If you are in need for a structured person with great communication skills, a good understanding of the regulatory environment, I can only recommend to reach out to Vaclav. Lucky you if he's not booked ;-) Besides all the success he's an enjoyable and humble character. Great experience to having worked with him.
Vaclav was for our company an immense help in the process of getting ISO 13485 certified. He set up lots of QMS relevant documents, implemented a project management system in our company to support the sprints, the ticketing system and the overall documentation and gave always valuable input for all questions which arised in the long certification process. Vaclav is a very reliable, friendly person with excellent knowledge in medical, technical and regulatory fields.I liked his humour a lot, especially in tensed situations he was able to smooth out waves of stress.His structured way of working and his communications skills helped a lot to move ahead with all involved stakeholders - no matter if international programming team, auditors or clients.I would love to work with him again and envy anyone who will - lucky you!
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.
We understand the regulatory environment. We have experience in implementing all standards related to medical software development, cybersecurity, and technical documentation, and we would be happy to demonstrate in practice how we can translate this expertise into real-world solutions while working on your medical device software product - as a developers a project managers.
- Real-World Solution for Your Organization
QMS Digitalization & Automation
Implement ISO 13485-compliant processes using Jira, Confluence, and SharePoint.
At QMLogic, we empower organizations to revolutionize their Quality Management Systems (QMS) with cutting-edge automation tools. Our expertise spans Microsoft SharePoint, Power Platform, Confluence, Jira, and custom-built solutions tailored to specific needs.
- Future of Quality Management
