Software-Enabled Products Expertise | The MedTech CRO

RQM+ provides regulatory, quality, clinical, post-market, and reimbursement support for medical devices and IVDs, including software-enabled products. Our expertise ensures compliance with FDA, EU MDR, and global standards, addressing AI/ML, cybersecurity, interoperability, and software life cycle management.

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Why RQM+ for Software-Enabled Products?

Cybersecurity

Compliance with FDA & EU MDR, security risk management, SBOM documentation, and threat mitigation.
Interoperability

Seamless data exchange, regulatory compliance, and alignment with HL7, FHIR, and DICOM.
AI/ML

Addressing algorithm bias, model drift, and regulatory approval for adaptive AI systems.
Software Development Life Cycle (IEC 62304)

Risk-based classification, validation, version control, and post-market compliance.

Applicable Regulations & Standards

Our expertise spans a wide range of therapeutic areas:

United States

FDA 21 CFR Part 820 – Quality System Regulation (QSR)
FDA 21 CFR Part 11 – Electronic Records and Signatures
FDA 510(k), De Novo, PMA – Regulatory pathways for medical devices
NIST Cybersecurity Framework – Cybersecurity risk management
IMDRF SaMD Guidance – Software as a Medical Device classification and compliance

Canada

Health Canada Medical Device Regulations (SOR/98-282) – Regulatory requirements for medical devices
ISO 13485:2016 – Quality management systems for medical devices
CSA Cybersecurity Standards – Security compliance for networked medical devices

Europe

EU MDR (2017/745) – Medical Device Regulation for compliance and market access
EU IVDR (2017/746) – In Vitro Diagnostic Regulation
ISO 14971 – Risk management for medical devices
IEC 62304 – Software lifecycle processes for medical device software
GDPR (General Data Protection Regulation) – Data privacy and security compliance

Integrated Solutions for Software-Enabled Devices

Expand each to see our key services.

Regulatory Strategy for Software (U.S. FDA & EU MDR) – Early classification (SaMD, SiMD), AI/ML regulatory strategy, and software change control planning aligned to 21 CFR 820, IMDRF, and EU MDR Annex XVI.
Cybersecurity Risk Modeling – Security-by-design strategy development, SBOM planning, and threat modeling per FDA and MDCG guidance.
AI/ML Transparency & Change Management – Early evaluation of algorithm bias, training data, adaptive learning risks, and regulatory impact assessments (FDA AI/ML action plan, EU AI Act readiness).
Interoperability Strategy – Planning for HL7, FHIR, and DICOM integration; alignment with U.S. and EU interoperability compliance frameworks.

IEC 62304 Software Lifecycle Compliance – Risk-based classification, lifecycle planning, traceability matrices, and documentation aligned to FDA and EU expectations.
AI/ML Validation Planning (U.S. & EU) – Drift mitigation protocols, training/testing dataset validation, algorithm update planning, and adaptive system tracking.
Cybersecurity-by-Design – Documentation for vulnerability management, access control, secure software architecture, and EU MDR Annex I & FDA premarket expectations.
Interoperability Documentation – Technical standards alignment (HL7, FHIR, DICOM), device-to-cloud integration, and real-world data enablement.
Clinical Study Design for AI – Protocol development and study support for adaptive and learning-based software models, including early feasibility and pivotal study planning.

Clinical Validation for AI/ML Software – Endpoint mapping, protocol execution, and regulatory study design tailored to software that adapts post-launch.
Real-World Data Integration & Continuous Learning – Strategy for collecting performance data in post-market settings to support algorithm updates under U.S. FDA and EU MDR frameworks.

Software Verification & Validation (IEC 62304) – Comprehensive test strategy, software verification documentation, automated test workflows, and validation traceability aligned with both U.S. and EU standards.
Cybersecurity Validation – Penetration testing, vulnerability scanning, and system hardening strategies in line with FDA premarket cybersecurity guidance and EU MDCG 2019-16.
Interoperability Verification – Confirming functional data exchange and compliance with HL7, FHIR, and DICOM protocols, and ensuring compatibility with external health IT systems.
AI Model Validation & Drift Monitoring – Evaluation of model performance, transparency reporting, and pre-sub documentation for adaptive algorithms.

QMS Alignment (ISO 13485, FDA 21 CFR 820) – Integration of software-specific processes, including lifecycle documentation (62304), cybersecurity, and version control.
Cybersecurity Patch Management Planning – Establishment of patch protocols and documentation for known vulnerabilities.
EU MDR Software-Specific Compliance – Annex I General Safety and Performance Requirements (GSPR) mapping and labeling strategy for software functions.

FDA & EU Regulatory Submissions for Software – Preparation and submission of 510(k), De Novo, PMA, and EU Technical Files (Annex II/III) for SaMD, SiMD, and AI-powered software.
AI/ML Transparency Documentation – Submission of model architecture, training data documentation, update strategy, and FDA pre-sub materials for algorithmic change control.
Cybersecurity Filing Compliance – Submission of SBOMs, threat models, and access control documentation; alignment with FDA and EU cybersecurity labeling expectations.
Interoperability Compliance Summary – Submission-ready summaries describing interface standards, integration testing, and external communication capabilities.

Launch Readiness for Software Products – Software labeling, cybersecurity disclosures, and final usability assessments specific to software regulatory requirements.
AI/Digital Health Reimbursement Planning – Coding and value story support for software reimbursement in the U.S. (CPT, HCPCS) and EU (NUB, G-BA, NICE).

AI Model Drift Tracking & Performance Monitoring – Systems to monitor, document, and justify algorithm retraining or performance changes post-launch.
IEC 62304-Compliant Update Documentation – Tracking and documentation of changes across software versions, including rationale and validation for each.
Cybersecurity Incident & Patch Reporting – Ongoing compliance with MDR vigilance, FDA post-market expectations, and incident mitigation strategy.
Interoperability & Data Exchange Risk Monitoring – Ongoing evaluation of data interfaces, real-world data sync issues, and ecosystem compatibility challenges.

Software Version Control & Change Management (62304) – Lifecycle traceability and update documentation compliant with regulatory expectations in U.S. and EU.
Adaptive Algorithm Update Support – Documentation and re-validation planning for model updates; pre- and post-market AI transparency reporting.
Re-submission Strategy for Software Enhancements – Support for new features, new intended uses, and EU MDR/IVDR delta assessments.

Flexible Partnering Solutions

Full-Service Outsourcing

End-to-end project ownership, from strategy to execution. Our managed outsourcing solutions enable easy collaboration, streamlined operations, and expert oversight so you can focus on what you do best.

Professional Consulting

Industry-leading MedTech consultants with the strategic insight and regulatory expertise to solve your toughest challenges. Our global team stays ahead of evolving regulations to keep your innovations moving forward.

Professional Staffing

Need an expert or a full team? We provide highly qualified MedTech professionals who integrate quickly and easily into your organization — the right people, right when you need them.

Regulatory & Compliance Support for Software-Enabled Medical Products

Ensure Compliance with FDA, EU MDR, and Global Standards

Why RQM+ for Software-Enabled Products?

Cybersecurity

Interoperability

AI/ML

Software Development Life Cycle (IEC 62304)