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.

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

“We deliver systems you can use, not reports you can read.”

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.”

Implementation That Works in Practice

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.

Turning Data Into Continuous Improvement

A sustainable QMS is driven by data. We help you establish key performance indicators (KPIs), data collection methods, and clear links between process metrics, management reviews, and CAPA activities. These are exactly the connections auditors expect to see, showing that your organization learns, adapts, and improves over time.

Establishment of measurable KPIs for key processes
Continuous monitoring for sustained compliance

Every effective system measures its performance, that’s what makes it reliable in the long term.

Connecting Audits, Reviews, and CAPA

Audits, management reviews, and CAPA are not separate checks; they are how a QMS demonstrates that it works. We build them directly into the implementation process, making them part of the system’s rhythm. This integration shows auditors that your organization doesn’t just react to findings, but that it continuously improves.

Risk-based audit and review planning
CAPA system integrated with trend analysis

Empowering People for Long-Term Sustainability

No QMS can survive without people who understand it. We make sure your teams know how to use it, maintain it, and benefit from it. This engagement is what keeps your QMS working, and what auditors always recognize as a sign of maturity.

“An effective QMS is one your people understand, use, and trust.”

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.

ISO 13485 Certification Audits Consulting

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

Preparation for FDA Inspections

We help medical device companies prepare for FDA inspections under the Quality Management System Regulation (QMSR, 21 CFR Part 820). Our goal is to ensure your system meets both U.S. regulatory expectations and ISO 13485 alignment requirements.

We provide:

FDA QMSR readiness assessments and mock inspections
Process and documentation review against FDA expectations
Remediation support for the previous 483 observations or warning letters
Training on the FDA inspection approach and the auditor mindset

ISO 13485 Certification for Medical Devices

We guide medical device manufacturers through the certification process, ensuring their products and quality systems fully align with ISO 13485 requirements.

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

Each audit is conducted in a constructive and collaborative way, focused on insights and understanding the idea behind the quality management system and the perspective from which auditors evaluate it.

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.

Explore how digital solutions transform QMS implementation

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

Q: Who needs a quality management system based on ISO 13485?

A: 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.

Q: Do we need an ISO 13485 quality management system as an importer of medical devices?

A: No. Importers are not required to implement a full ISO 13485 quality management system or hold certification. However, under EU MDR Article 13, FDA 21 CFR 806, and Health Canada CMDR/MDSAP requirements, importers must have documented procedures ensuring that imported devices comply with all regulatory obligations. These include verifying CE marking and technical documentation (for E.U.), ensuring that devices come from MDSAP-certified manufacturers (for Canada), and maintaining processes for traceability, complaint handling, and incident reporting across all regulated markets.

Q: How long does it take to implement a QMS based on ISO 13485?

A: The time needed to implement an ISO 13485–based QMS depends on the size, structure, and complexity of your organization.

For smaller companies establishing a QMS from the ground up, typically with 10–40 employees, it is feasible to complete the full implementation within 3 to 4 months, provided that decision-making is efficient and the project is well-coordinated.

For larger organizations with more complex structures, extensive documentation, and numerous interlinked processes, implementation or transition projects can range from 6 to 18 months, depending on the level of QMS redesign and system integration required.

Q: How can we accelerate QMS implementation?

A: Speeding up QMS implementation is about focus, structure, and clear responsibilities.

For smaller companies and startups, the fastest approach is to start with a set of predefined, proven QMS documents and adapt them to your organization. The goal is feasibility, not unnecessary complexity. We take care of the full implementation, designing and connecting all processes efficiently, and avoiding common pitfalls seen during audits. Once the system is complete, we hand it over to your Quality Management Representative, train your team, and remain available for ongoing support.

For larger organizations, successful and timely implementation depends on a clearly defined scope, clear objectives, and realistic boundaries. It is essential to set what will be done now and what will be addressed in later phases, so the effort stays focused and leads to measurable results.

We can lead the transformation and manage the workload, but the key decisions must come from within your organization. Every QMS transition requires commitment and resources and may temporarily shift focus from other activities. It is therefore essential that the organization decides to move in this direction and fully supports the implementation effort from the start.

Joint workshops at the beginning help define the scope, goals, and expectations, ensuring that decisions are made quickly and consistently throughout the project.

Q: Is ISO 13485 implementation alone sufficient for medical device manufacturers?

A: Implementing ISO 13485 provides the essential foundation for a medical device quality management system, but in most cases, it is not sufficient on its own. The standard defines core requirements but often references other processes without detailing how they should be managed; for example, design and development controls, technical documentation, or risk management integration, where it is necessary to apply and integrate additional ISO and IEC standards.

Additional requirements arise from jurisdiction-specific regulations such as FDA 21 CFR QMSR, EU MDR, and the Canadian Medical Device Regulations (CMDR). These frameworks introduce specific obligations for post-market surveillance, vigilance, clinical follow-up, and periodic safety reporting, as well as for recall management, labeling and packaging controls, device registration, and oversight of import and distribution activities. Addressing these areas within your QMS ensures complete and consistent compliance across all regulatory markets.

We help you integrate these complementary requirements into your QMS so that your system functions as a complete, compliant, and globally aligned framework.

Q: Which other standards should be part of a QMS?

A: The additional standards to be integrated into your QMS depend on the type and intended use of your medical device. Beyond jurisdiction-specific regulations such as the U.S. QMSR, EU MDR, or Canadian CMDR, most manufacturers also implement ISO 14971 for risk management.

If you develop medical software, standards such as IEC 62304, IEC 82304, or IEC 81001-5-1 will apply. For needle-based injection systems, the relevant standard is ISO 11608, while electrical medical device manufacturers must comply with IEC 60601-1 and its collateral standards.

Each product category has its own applicable set of requirements, and we can help you integrate them into a single, compliant, and efficient QMS framework.

Q: We already have QMS documents and templates, is that enough for an audit or FDA inspection?

A: Having documents and templates is a good start, but it’s not enough to pass an audit or FDA inspection. Auditors look beyond what is written, they want to see how your quality management system actually works in daily practice.

It’s not about having a folder full of procedures; it’s about showing that your team follows them, understands them, and uses them to make decisions. A QMS must be a living system, something that connects management with the rest of the organization, helps evaluate how processes perform, and ensures that your products remain safe and compliant.

The real challenge is not creating documents, but building a QMS system that truly reflects how your company operates. A system that is practical, sustainable, and part of your everyday work.