Medical Device Software Consulting (SaMD/MDSW)

Implementation That Connects Standards, People, and Purpose

From Requirements to a Living System

We help you implement a quality and regulatory environment for your medical device software that is not just compliant but also works for your organization. Such a solution will reflect your philosophy, structure, and daily reality, connecting people, processes, and objectives into one functioning unit.

Seeing the Bigger Picture

We will guide you through specific standards, but our real focus is on helping you to see how all those standards connect and work together as one coherent system.

We speak your language

We understand that your goal is not only to be compliant but also to succeed in the market, staying innovative, effective, and fast enough to outpace the competition while delivering safe, high-quality products.

Unifying Compliance and Business Services

We recognize that compliance is not the only priority in your organization. You have your business plans, release deadlines, and team objectives. We don’t place regulatory or quality activities above all others; instead, we demonstrate how every department can collaborate to achieve its goals in alignment: be fast, compliant, and efficient at the same time.

Bridging Perspectives Across Your Organization

Mutual understanding between people and departments is essential. We believe that every team in your company cares about quality; sometimes, they just see it differently in terms of what quality means or how it can be achieved. We help align those perspectives so that quality becomes a shared language, not a point of friction.

Let’s Build an Environment People Love to Work

We will help you create a compliant environment that your employees understand, where they work faster, communicate better, and enjoy being part of a meaningful and modern quality management system.

The Regulatory Backbone of Medical Device Software

QMLogic offers a complete complete consulting services for the medical device software lifecycle.

The standards we work with form the foundation of compliance for any company developing software in a regulated medical device environment.

Over the years, we have supported our clients in many areas, from building quality management systems and shaping regulatory strategies to implementing risk management and cybersecurity processes and integrating them into modern eQMS solutions.

Through this work, we have built deep expertise across the complex ecosystem of standards and regulations for both the European and American markets.

This allows us to offer our clients comprehensive consulting for medical device software, combining both regulatory and technical perspectives.

From Regulatory Layers to One Logical System

Each of the main medical device standards and regulations addresses a specific aspect of the same reality. They are not isolated documents; together they define a connected network of activities that cover the entire software lifecycle, from design and development, through maintenance, to monitoring effectiveness and safety in the market.

Instead of letting processes and standards exist side by side, we integrate them together, ensuring that your organization works as one well-orchestrated system.

“We implement standards into a practical framework tailored to your organization's needs.”

Implementing the Regulation to Fit Your Organization

We combine regulatory knowledge with a practical reflection on how your organization develops, including its size, structure, and pace of growth.

Every company we work with is at a different stage of its journey. Some are building their first systems, others are scaling fast after investment, and many are optimizing mature quality environments.

We adapt to your context, your size, structure, and priorities, to design solutions that make sense for you now and create a foundation for where you want to go next.

We approach compliance with practicality. For smaller teams, it means helping you establish what’s essential and effective without unnecessary complexity. For larger organizations, it’s about increasing efficiency, avoiding redundant activities, and keeping compliance fully integrated into complex company operations.

“Regulatory compliance will be built around your organization’s dynamics.”

Our focus is always on connection: teams, systems, and the alignment of business and regulatory objectives. The result is a quality environment that evolves naturally with your organization.

Comprehensive Compliance Implementation Services

From Medical Device Strategy to TechDoc Creation

Compliance is more than interpretation. Our compliance services combine consulting expertise with practical implementation.

“We don’t stop at explaining what needs to be done; we help you make it happen.”

Hands-on Compliance Implementation and QMS Transformation

We act as an extension of your team, translating regulatory requirements into practical actions.

Our team will help you:

Identify and interpret applicable regulations and standards for your products and markets.
Integrate missing elements into your existing quality management system.
Connect requirements across different standards to form one coherent structure.
Develop and adapt internal procedures that reflect your organization’s size, maturity, and workflow.
Prepare and deliver training to ensure your teams understand and apply these processes effectively.
Support you during internal and external audits, including preparation and follow-up.
Adapt and optimize your QMS based on audit results or regulatory updates.

Support Across the Whole Medical Device Software Lifecycle

Our involvement covers the entire medical device software lifecycle, from the first idea to post-market activities:

Regulatory strategy consulting - defining product classification and compliance pathway.
Planning, design, and development - ensuring technical documentation and records are aligned with standards.
Risk management and cybersecurity - building robust files and integrating them into your product lifecycle.
Maintenance and post-market surveillance - supporting continuous compliance and performance monitoring.

Whether you need to design, connect, or transform specific parts of your regulatory and compliance environment, we help you do it efficiently and in line with all relevant regulations, such as ISO 13485, ISO 14971, IEC 62304, MDR 2017/745, and 21 CFR 820.

“From regulatory concept to working process — we make compliance tangible.”

Building a Digital Quality Management as the Core of Sustainable Compliance

Implementing and maintaining compliance in the medical device software industry is no longer possible without a modern, digital foundation.

Interpretation of standards, consulting, and even implementation efforts lose their long-term value if they are not supported by an effective electronic Quality Management System (eQMS).

A well-implemented eQMS extends far beyond traditional quality management. It connects:

Process management and design controls for technical documentation
Risk management and cybersecurity
Post-market surveillance and continuous improvement activities

We believe that long-term compliance can only be achieved through functional and monitored digital solutions. These modern QMS tools ensure that your organization remains compliant while staying agile, modern, and efficient.

Many companies hesitate to digitalize their QMS, often fearing that tools won’t fit their structure or won’t pass regulatory audits or FDA inspections.

But true risk lies not in transformation; it lies in stagnation. The absence of a properly implemented eQMS leads to regulatory overhead, inefficiency, and growing maintenance costs.

We help you design and implement digital solutions that:

Reflect all applicable standards and your specific organizational needs
Strengthen communication and collaboration between teams
Reduce operational costs and compliance risks
Support long-term scalability and continuous improvement

Your QMS defines how your organization operates. But writing a process is only the first step. The real transformation happens when these processes come to life within a modern digital environment that is used by your people every day.

Let’s build together a modern, connected infrastructure for your organization; one that supports all standards seamlessly and turns your QMS into a system of operational excellence, not just compliance.

“Transformation happens when processes stop being described and start being lived.”

Quality and Regulatory Affairs Consulting Services

We provide complete medical device software consulting and compliance implementation services that cover the full journey, from defining your regulatory strategy and designing compliant internal processes to implementing all relevant standards and regulations within one coherent, interconnected system.

The set of standards and regulations is closely related; they address similar challenges from different perspectives, and when implemented together, they naturally reinforce one another.

In the following sections, we illustrate how these frameworks connect, how compliance with one strengthens your alignment with others, and why we focus specifically on this set of standards.

The following standards are the ones most relevant to medical device software, and are the ones every organization will encounter when building a compliant, safe, and modern medical device organization.

“We will help you to build an environment that is compliant, consistent, and efficient, avoiding redundancy and unnecessary complexity.”

Medical Device Regulation (EU MDR 2017/745): The European Regulatory Umbrella

The EU Medical Device Regulation (MDR) defines the legal framework for all medical devices placed on the European market. It applies to every organization developing, manufacturing, or distributing medical devices within the European Union.

MDR establishes the obligation to operate a Quality Management System (QMS) — typically implemented in line with ISO 13485. It also defines requirements for technical documentation, including a risk management file and cybersecurity documentation as outlined in IEC 62304, ISO 14971, and IEC 81001-5-1.

Beyond product-specific requirements, MDR also governs:

Device classification and conformity assessment routes
Certification procedures and interactions with notified bodies
Post-market surveillance and vigilance activities

We will help you interpret and apply these requirements strategically, guiding you through MDR classification, certification, and compliance planning. Together, we define the right regulatory pathway that supports your product and business goals.

See how we can navigate you through EU MDR

21 CFR – Medical Devices Under FDA

What the EU MDR represents for the European market, Title 21 of the Code of Federal Regulations (CFR) defines for medical devices in the United States.

Subchapter H of these regulations covers the same areas of the product lifecycle, from design and development to market approval and post-market activities.

It includes:

Requirements for a Quality Management System (QSR – 21 CFR 820.30)
Design and development controls
Premarket approval and device classification procedures
Post-market surveillance and Unique Device Identification (UDI)

We will help you build a compliant and effective quality system fully aligned with the requirements of 21 CFR.

For organizations operating in both the U.S. and European markets, we ensure that your processes under 21 CFR and EU MDR work together as one coherent framework, reducing duplication and maintaining a single, efficient system across regions.

See how we can help you achieve compliance under 21 CFR

ISO 13485: Quality Management System (QMS) for Medical Devices

ISO 13485 is the cornerstone standard for organizations developing and bringing medical devices to market. It lays out the requirements for a Quality Management System (QMS) to ensure consistent product quality and safety.

ISO 13485 doesn't specify how a product should be designed or developed; it is more about the operational measures of your company.

We will help you implement ISO 13485 in a way that strengthens efficiency and supports the operational excellence of your company.

See in detail how we can support you with ISO 13485

21 CFR 820 and ISO 13485 — One Harmonized Quality System

21 CFR 820, also known as the Quality System Regulation (QSR), is the American equivalent of ISO 13485. It covers the same key areas — from general quality system requirements and design controls to document management, traceability, and corrective and preventive actions (CAPA).

With the FDA Quality Management System Regulation (QMSR) now incorporating ISO 13485 by reference, the U.S. framework is being harmonized with this international standard.

This alignment simplifies global compliance and allows organizations to maintain a unified approach to quality management across markets.

We will help you align 21 CFR 820 with ISO 13485 and prepare for the transition to the QMSR (Quality Management System Regulation), which comes into effect on February 2, 2026.

We help you integrate ISO 13485 into your 21 CFR 820 system efficiently, avoiding duplication and ensuring full compliance with both frameworks.

See how we can support you in this transformation

IEC 62304: Software Development Lifecycle for SaMD/MDSW

IEC 62304 focuses specifically on the software lifecycle, covering:

Initial planning
Design and development
Implementation and verification
Ongoing maintenance
Decommissioning and market withdrawal

This standard ensures that every phase of the product’s lifecycle is controlled and documented.

We know your development team already follows structured workflows. Our role is to connect those day-to-day practices with the requirements of IEC 62304, so you can be sure that your existing development practices meet regulatory expectations.

And if there are some standard requirements not yet fully covered, we help you link them naturally to the rest of your activities, shaping them in a way that fits your organization’s logic and pace.

Explore our support for software lifecycle and technical documentation

ISO 14971: Risk Management for Medical Devices

No medical device can reach the market without a proper Risk Management System, which is the focus of ISO 14971.

This standard emphasizes:

Identifying potential risks
Evaluating and mitigating those risks
Continuously monitoring risks throughout the product’s lifecycle

We help you understand what risk management truly means for your product and development processes, how it connects to software safety classification, requirements engineering, software design, and cybersecurity.

The result is a logical, consistent set of activities ensuring that the products your team builds are safe, reliable, and protect patients from harm.

See how we can support you with risk management and product safety

IEC 81001-5-1: Cybersecurity for Medical Software

In today’s world of interconnected software systems, spanning mobile devices, local networks, and cloud platforms handling sensitive data, cybersecurity has become an essential part of medical software development.

The IEC 81001-5-1 standard defines the framework for managing security risks with the focus on:

Identifying and assessing threats and vulnerabilities
Implementing and maintaining appropriate security controls
Continuous security monitoring of your product

We help your team understand these cybersecurity principles and select the right activities to address them logically and effectively.

Together, we build secure products by design, connecting cybersecurity tasks with risk management (ISO 14971) and software lifecycle activities (IEC 62304).

Learn more about our cybersecurity support

ISO 27001: Information Security Within Your QMS

Medical device software, especially cloud-based or interconnected solutions, processes vast amounts of data. These data vary in nature, but many include highly sensitive patient information. In this context, ensuring the confidentiality, integrity, and availability of data is critical.

ISO 27001 provides the framework for establishing an Information Security Management System (ISMS), a structured approach to protecting sensitive information within your organization.

While not directly mandated for medical device manufacturers, it is widely recognized as a supporting standard for compliance with GDPR, HIPAA, EU AI Act, or EU MDR requirements regarding data integrity, privacy, and confidentiality.

There are also strong connections between ISO 27001 and quality management system standards such as ISO 13485 or 21 CFR 820.

We will help you connect these areas and build one integrated system that addresses all types of sensitive data, from patient information to confidential partner contracts, employee records, and financial data.

See how we support ISO 27001 integration into your QMS

ISO 42001: Managing Artificial Intelligence Within Your QMS

ISO 42001 is the world’s first standard for Artificial Intelligence Management Systems (AIMS).

As AI becomes an inseparable part of modern technology and medical device software is no exception. Whether you use AI in your internal operations as part of your QMS or within your medical device products, ISO 42001 offers a comprehensive framework for managing this technology responsibly and effectively.

While it introduces new concepts such as ethical AI principles, it also closely connects with established standards. There are strong overlaps with information security concepts (ISO 27001), software lifecycle standard (IEC 62304), or risk management standard (ISO 14971).

Leveraging these existing structures allows your organization to integrate AI management naturally, without creating silos and unnecessary overhead.

We support companies in seamlessly embedding ISO 42001 into their quality management systems and development practices, ensuring consistency and traceability across all related processes.

See how we can connect ISO 42001 with the rest of your QMS

IVDR for Software-Based Diagnostics: Connecting Science, Software, and Compliance

For software-based in vitro diagnostic (IVD) products, compliance means bridging two worlds: the scientific and clinical requirements of the IVDR, and the technical and software standards that ensure product reliability and safety.

We will support you in creating IVDR-specific technical documentation, including:

Performance Evaluation Plans and Scientific Validity Reports
Declarations of Conformity
Post-Market Performance Follow-Up Plans (PMPF)
Summaries of Safety and Performance (SSP)

Our team brings together PhD-level experts in clinical and laboratory fields with experienced professionals in medical device software development.

This enables us to connect IVDR-specific requirements with the right software standards, such as:

IEC 62304 – software lifecycle processes
ISO 14971 – risk management
IEC 81001-5-1 – cybersecurity for connected or networked IVD systems

The result is a holistic, integrated approach covering every aspect of compliance, such as clinical, laboratory, regulatory, software, or cybersecurity.

Learn how we can assist you with IVDR compliance

ISO 80002-2: Lean and Reliable Computer System Validation

Computer System Validation has a special place in our services. We believe that digitalization and automation should empower quality management, and we will help you transform validation into a lean process that benefits your organization.

Too often, organizations hesitate to integrate digital tools into their quality management systems or operational environments out of fear that validation will be too complex, time-consuming, and costly. As a result, many computer systems remain underused, or worse, left unvalidated in the shadows.

We combine our risk-based approach based on our clinical expertise, deep understanding of software lifecycles, information security, and passion for digital operations, which makes CSV efficient, logical, and value-driven.

We have built and validated numerous our own software solutions, and we have also supported complex validation projects for major medical device manufacturers where the validation results have been finally successfully approved by regulatory authorities.

Proper validation does not have to be a burden. When done right, it gives your organization the confidence that every software system you rely on functions reliably, without threatening business continuity, product quality, or patient safety.

See how we can simplify your computer system validation

CAPA – Remediation Services for Your QMS

We know that CAPA can be one of the most demanding parts of a quality management system. Many teams find it complicated, slow, and even frustrating, especially when they know it’s the area that notified bodies always look at closely.

That is why we come in. Our CAPA consulting combines our deep knowledge of regulations with practical, hands-on experience from transforming real quality systems. We have worked on hundreds of CAPAs, and we’re not afraid to go deep to uncover the real causes. Not just to “close” a CAPA, but to fix what isn’t working in your company.

We’ll guide you through every step, from identifying the problem to evaluating the effectiveness of your actions.

You’ll end up with CAPAs that are clear, focused, and meaningful, not just compliant.

Your organization will see what caused the issue, what was done to fix it, and how well the solution actually worked.

For us, every CAPA is an opportunity to make your system stronger and more efficient. And we’ll also show you how to manage future nonconformities on your own, with confidence and structure.

See how we can support your CAPA process

Internal Audits: Practical Insight from Both Sides of the Table

We know audits from both sides. Over the years, we’ve audited many companies, assessing their readiness for EU MDR certification, the effectiveness of their quality management systems, and the completeness of their technical documentation, including risk management and cybersecurity files.

At the same time, we’ve also stood on the other side, being audited as process owners, quality management representatives, and regulatory affairs specialists in various organizations.

That is why our auditing services always bring both perspectives. We understand what auditors need to see, as well as what it is like to manage the complexity of compliance from within an organization.

When we audit your processes or technical documentation, we go beyond a simple checklist. We help you understand what might cause problems in the future, identify areas where your system could become unsustainable, and recognize what external auditors typically focus on.

You will receive not just an audit report, but a practical assessment with clear guidance, proposed improvements, and a detailed evaluation of your current status before an upcoming inspection or technical documentation submission.

See how we can support you with internal audits

NIS2 – Integration of Cybersecurity and Governance Into Your QMS

Implementation of the NIS2 Directive is another area where we support our clients by helping them integrate this new European regulation into their existing operational and governance structures.

We build on the standards and frameworks many organizations already know well, such as ISO 27001, ISO 27002, and IEC 81001-5-1. These serve as a strong foundation for NIS2 implementation, especially in areas like data privacy, business continuity, and disaster recovery.

With our support, you will establish a comprehensive management system that fully incorporates NIS2 requirements into your quality and information governance. This includes defining and implementing processes such as incident handling, reporting procedures, and risk-based controls.

The result is an integrated environment where NIS2 becomes a natural part of your existing QMS, not a separate system, but one coherent framework following a GRC (Governance, Risk, and Compliance) approach.

See how we can support you with NIS2 integration

EU AI Act — Integrating Artificial Intelligence Regulation Into Your QMS

With our set of regulatory and standard implementation services, we also help our clients achieve compliance with the new EU AI Act, a comprehensive European regulation governing the safe and responsible use of artificial intelligence.

As with other regulatory frameworks, the most effective approach is to build the required processes on top of your existing management system, rather than creating overlapping or redundant procedures.

For AI-based medical device software, the EU AI Act almost always applies, as these systems are typically classified as high-risk.

However, compliance can be built efficiently using standards you may already apply, including:

IEC 62304 for software lifecycle processes
ISO 14971 for risk management
IEC 81001-5-1 for cybersecurity
ISO/IEC 23894 for AI-specific hazards and risks identification

We help you review your current setup, identify process gaps in the context of the EU AI Act, and integrate the required controls and documentation seamlessly into your existing QMS and development framework.

See how we can support your compliance with the EU AI Act

510(k) and PMA — Complete Support for U.S. Market Entry

We help companies with every aspect of 510(k) and PMA submissions, from defining the right regulatory pathway to preparing and managing complete submission packages.

It all starts with regulatory strategy and planning by determining the appropriate pathway, identifying predicate devices, and mapping out the required documentation.

From there, we support you in preparing:

Technical documentation aligned with IEC 62304 and 21 CFR 820.30, and ready for submission
Risk management files compliant with ISO 14971
Cybersecurity documentation and related records

We also assist with FDA interactions, including pre-submission meetings, responses to FDA questions, and follow-up actions after submission.

With our experience, you gain a trusted partner for the entire process, ensuring your submission is complete, compliant, and strategically positioned for success on the U.S. market.

See our services for 510(k) and PMA submissions