ISO 13485
Medical Device Compliance
Medical Device Software Consulting (SaMD/MDSW)
IEC 62304
Guiding the Software Lifecycle
ISO 14971
Managing Risks Effectively
IEC 81001-5-1
Addressing Cybersecurity Risks
EU MDR
Medical Device Regulation
NIS2
Compliance & Cybersecurity
ISO 27001
Organizational Data Security
AI EU Act
Health AI Systems
FDA Regulations
Aligning with U.S. Standards
ISO 42001
AI Management Systems
21 CFR Part 820
U.S. Quality System Regulation
EU IVDR
In Vitro Diagnostic Regulation
ISO 80002-2
Computer System Validation
CAPA
Corrective and Preventive Actions
Internal Audits
Quality System Evaluation
Standards, People & Purpose Connected Together
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.
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.
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.
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.
Complete Regulatory Framework
QMLogic offers a 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 eQMSsolutions.
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.
Connected. Compliant. Streamlined.
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.
Regulation Fitting 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.
We Do the Work
From Regulatory 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
A Hands-on Team by Your Side
We embed directly into your team, providing hands-on support for process development, technical documentation, and QMS digitalization.
Our team will help you:
- Identify applicable regulations and standards
- Develop missing internal procedures
- Prepare and deliver training
- Support you during audits
- Optimize and digitize your QMS
- Solve your CAPAs and audit findings
Support in the Whole Product Lifecycle
From regulatory concept to working process; making compliance tangible.
Our involvement covers the entire medical device software lifecycle, from the first idea to post-market activities:
- Regulatory strategy consulting
- Planning, design, and development
- Risk management and cybersecurity
- Maintenance and post-market surveillance
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.
Digital Quality Management, Your Compliance Core
eQMS for Modern Quality Management
Long-term compliance in the MedTech industry cannot be maintained without a modern digital solution.
Without an effective eQMS, even the best implementation is not maintainable long-term.
We deploy a modern QMS system that covers:
- Management of Documents & Records
- Technical Documentation
- Risk management and cybersecurity
- CAPA, Audits, Supplier Management, and many more
Validated & Compliant Digital Solution
Don't worry that the eQMS tool won't fit your organization or pass regulatory audits or FDA inspections.
Our solution is designed to meet the strictest medical device and IVD requirements.
Alongside compliance, you get a system that:
- Reflects not only regulations, but also your specific needs
- Strengthens teams' communication and collaboration
- Reduces operational costs and speeds up work
- People like to use
Achieve long-term compliance through modern and functional digital solution.
Remain compliant while staying agile, modern, and efficient.
Writing processes is only the first step, the real transformation happens when the processes come to life within a modern environment that is used by your organization every day.
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.
Compliant, consistent, and efficient environment that avoids redundancy and unnecessary complexity.
Your Partner in Medical Devices & IVD
Digitalization and Automation for QMS and Regulatory Affairs
At QMLogic, we empower organizations to revolutionize their Quality Management Systems (QMS) with cutting-edge digitalization and automation tools. Leveraging Jira, Confluence, SharePoint, Power Platform, and custom-built solutions, we design efficient, automated, and ISO 13485-compliant systems tailored to your unique needs.
- Future of Quality Management
Medical Device Software Development (SaMD/MDSW)
Medical Device Software Development
QMLogic delivers trusted medical device regulatory consulting services and medical device regulatory compliance software support, guiding you from development to successful certification.
- Software Development
- Technical Documentation
- Medical Project Management
- Regulatory Compliance
Get consultancy for free
Ask anything you need to know about Medical Software, CE certification or MDR.
