Regulatory Affairs Consulting for Medical Device Software (SaMD/MDSW)
Regulatory Compliance and Market Readiness for SaMD Solutions
QMLogic offers expert regulatory affairs consulting services for medical device software (SaMD/MDSW), ensuring compliance with global standards such as ISO 13485, IEC 62304, and EU MDR. Our tailored approach to medical device consulting services supports companies in achieving both technical excellence and full market readiness while addressing cybersecurity, risk management, and AI-specific requirements.
Why Choose QMLogic for Medical Device Consulting?
At QMLogic, we are more than a consultancy, we are your hands-on partner for the whole medical device life cycle, specializing in regulatory compliance consulting, quality management, software development, risk management, and cybersecurity and AI in the healthcare.
With extensive experience guiding companies through ISO 13485, IEC 62304, ISO 14971, ISO 27001, ISO 42001 or IEC 81001-5-1 standards, we deliver practical solutions that work for your specific organizational needs and business goals.
Comprehensive Medical Device Software Services
We specialize in a specific set of standards and norms required for the development and market introduction of medical device software.
The overlap and interconnection of these standards form the foundation of our medical device services. By addressing each standard and ensuring they work harmoniously, we provide a comprehensive solution for medical device software companies, helping them navigate complex requirements and bring their products to market with confidence. Our medical device regulatory consulting services address the entire product lifecycle and regulatory pathway of SaMD/MDSW products.
Let QMLogic help you streamline these standards into a cohesive and practical framework tailored to your organization's needs.
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's 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.
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IEC 62304: Software Development Lifecycle for SaMD
IEC 62304 focuses specifically on the software lifecycle, covering:
- Initial 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. It works hand-in-hand with other standards to ensure a seamless process.
See moreISO 14971: Risk Management for Medical Devices
No medical device can reach the market without a robust 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
ISO 14971 must be tightly integrated with IEC 62304 to align risk management with the design and development processes. Implementing these standards in isolation would lead to inefficiencies and gaps in compliance.
See moreIEC 81001-5-1: Cybersecurity for Medical Software
Cybersecurity risks are becoming increasingly significant, warranting a dedicated standard: IEC 81001-5-1. Unlike traditional risk management outlined in ISO 14971, this standard focuses on managing technical risks, such as:
- Threat identification
- Vulnerability management
- Security controls specific to medical software
Cybersecurity and risk management must work together to provide a complete picture of potential threats, ensuring both patient safety and data security.
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Medical Device Regulation (MDR): The Umbrella Framework
The EU Medical Device Regulation (MDR) serves as the overarching regulatory framework that consolidates all requirements from ISO 13485, IEC 62304, ISO 14971, and other standards.
In addition to these, MDR also emphasizes:
- Privacy and handling of medical data
- Organizational-level data security measures, such as backups and controlled access
Here, the connection to IEC 81001-5-1 becomes evident, as cybersecurity is a critical aspect of compliance.
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NIS2 Compliance & Cybersecurity Consulting
NIS2 is the updated EU cybersecurity directive, applying to essential sectors like healthcare and medical devices.
It sets stricter requirements for risk management, incident response, and supply chain security, with mandatory breach reporting within 24 hours.
It complements standards like ISO 27001 and IEC 81001-5-1 by enforcing organization-wide cybersecurity readiness.
- Risk and supply chain assessment
- Defined cybersecurity roles and policies
- Rapid detection and reporting of incidents
- Alignment with MDR and cybersecurity standards
ISO 27001: Information Security Management
While IEC 81001-5-1 addresses product-level cybersecurity, ISO 27001 focuses on broader organizational data security, including:
- Data storage and access management
- Backup systems
- Incident response planning
Though not mandatory, ISO 27001 offers a comprehensive framework for managing information security risks. For mandatory compliance in Europe, organizations must also consider NIS 2 requirements.
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AI EU Act Health AI Systems
Artificial intelligence (AI) is increasingly integrated into medical device software. The EU AI Act sets the normative framework for AI systems, which must be implemented in alignment with other standards like:
- IEC 22989 for AI concepts and terminology
- IEC 23053 for AI explainability
- IEC 23894 for managing AI risks
For a holistic approach to medical device software, AI compliance cannot be overlooked.
See moreISO 42001: AI Management Systems for Healthcare and Medical Devices
ISO 42001 is the world’s first standard for Artificial Intelligence Management Systems (AIMS).
It provides a framework for governing, developing, and deploying AI responsibly in healthcare and medical devices.
- Governance of AI risks and ethical considerations
- Alignment with the EU AI Act and sector-specific standards
- Ensuring trustworthy, transparent, and explainable AI
- Integration of AI into existing QMS and regulatory frameworks
With ISO 42001, organizations can demonstrate accountability, manage AI risks, and prepare for evolving global AI regulations.
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FDA 21 CFR Part 820: U.S. Quality System Regulation (QSR)
FDA 21 CFR Part 820 outlines the Quality System Regulation (QSR) for medical devices marketed in the U.S. It closely mirrors ISO 13485 but includes FDA-specific requirements for design, manufacturing, and post-market control.
- Design Controls (21 CFR 820.30)
- Document control and recordkeeping
- Corrective and Preventive Actions (CAPA)
- Production and process validation
Compliance with 21 CFR Part 820 is essential for FDA inspections and market access, and we help companies align seamlessly with both ISO 13485 and FDA requirements.
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IVDR: In Vitro Diagnostic Regulation
The EU IVDR 2017/746 sets rigorous requirements for in vitro diagnostic devices, replacing the IVDD.
It expands the scope and introduces stricter rules for clinical evidence, performance evaluation, and post-market surveillance.
- Device classification under IVDR
- Technical documentation and performance studies
- Integration with ISO 13485 and risk management (ISO 14971)
- Post-market performance follow-up (PMPF)
We guide companies through IVDR compliance to ensure their IVD products meet the latest EU regulatory expectations and gain market approval.
See moreISO 80002-2: Computer System Validation (CSV)
ISO 80002-2 provides practical guidance for validating software used in regulated environments, such as QMS, LIMS, or ERP systems.
This ensures systems used in design, production, or quality management are reliable and compliant.
- Risk-based validation of software tools
- Documentation of system requirements, testing, and validation results
- Alignment with FDA Part 11 and EU Annex 11 for electronic records
- Ensuring data integrity and traceability
We help organizations achieve efficient, compliant CSV without overburdening their teams.
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CAPA: Corrective and Preventive Actions
A robust CAPA process is the backbone of any Quality Management System.
CAPA ensures that issues are not only corrected but prevented from recurring, satisfying both ISO 13485 and FDA 21 CFR 820 requirements.
- Root cause analysis and systemic remediation
- Preventive actions for risk mitigation
- Digitalization and automation of CAPA workflows
- Integration with audits, complaints, and post-market surveillance
We help you build a CAPA system that goes beyond compliance, driving continuous improvement and operational excellence.
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Internal Audits: Independent Quality System Evaluation
Internal audits are more than a compliance checkbox — they are a powerful tool to identify risks, inefficiencies, and opportunities for improvement.
Both ISO 13485 and FDA QSR require regular, independent audits to ensure ongoing compliance.
- Planning and execution of risk-based internal audits
- Gap analysis against ISO, FDA, and MDR/IVDR requirements
- Training your team for effective audit readiness
- Preparing for Notified Body audits and FDA inspections
With our structured audit approach, your organization can ensure compliance, readiness, and continual improvement.
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FDA Regulations: Aligning with U.S. Standards
For organizations targeting the U.S. market, FDA regulations must also be factored in. These regulations complement the ISO and IEC standards by defining specific requirements for:
- Design controls (21 CFR 820.30)
- Electronic records (21 CFR Part 11)
- Submission processes like 510(k) for market entry
Your Trusted Partner in Medical Device Regulatory Compliance
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.
Medical Device Software Development (SaMD/MDSW)
QMLogic delivers trusted medical device regulatory consulting services and medical device regulatory compliance software support, guiding you from development to successful certification.
- Software Development
- Medical Project Management
- Technical Documentation
- Regulatory Compliance