Medical Device Software | Regulatory Guidance

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.

Start Now

Why RQM+ for Software-Enabled Products?

Cybersecurity

Compliance with FDA and 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

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 (US & EU)
- Product classification (SaMD vs. SiMD vs. software accessory)
- Intended use and claims shaping
- IMDRF framework and MDR Annex VIII classification
- Early regulatory pathway strategy (e.g., 510(k), De Novo, PMA, CE Mark under MDR)
  Documents: Regulatory strategy, classification rationale, initial claims matrix
Quality
- SDLC alignment to IEC 62304, ISO 13485
- Cybersecurity planning per AAMI SW96 and ISO/IEC 81001-5-1
  Documents: Risk management plan, draft development SOPs
Clinical
- Evidence needs assessment for software-specific performance and human factors
  Documents: Early clinical evidence roadmap
Reimbursement
- Initial payer value story exploration
- Identification of digital health reimbursement pathways (e.g., NTAP, CPT codes)
  Documents: Reimbursement landscape summary
Medical Writing
- Drafting of intended use, IFU outline, early labeling strategy
  Documents: Draft IFU, Target Product Profile
Labs (Jordi Labs)
- Only applicable for wearable/implantable devices with sensors
  Documents: N/A unless hardware present

Regulatory
- Pre-submission strategy (FDA Q-Sub, EU NB consultations)
- Standard applicability mapping (FDA Guidance, IEC 62304, ISO 14971)
  Documents: Pre-sub package, regulatory standard applicability matrix
Quality
- Software development documentation including version control, requirements traceability
- Secure design documentation and cybersecurity control planning
  Documents: SDLC documentation, configuration management, secure design traceability
Clinical
- Protocol planning for usability testing and validation
- Simulation or observational design for performance substantiation
  Documents: Usability test plan, clinical validation framework
Reimbursement
- Planning for evidence to support payer discussions
  Documents: Preliminary value dossier outline
Medical Writing
- Support protocol development, IFU drafting, early CER skeleton (EU)
  Documents: Draft protocol, CER framework, labeling overview
Labs (Jordi Labs)
- For wearable/implantable: initiation of device-software integration feasibility testing
  Documents: N/A unless hybrid product

Regulatory
- Support for software V&V documentation aligned to claims
- Traceability matrix development and Level of Concern justification
  Documents: V&V summary, traceability matrix, Level of Concern documentation (FDA)
Quality
- Ensure all IEC 62304 and ISO 14971 documentation is audit-ready
- Cybersecurity verification protocols documented
  Documents: Software verification plan, risk control documentation
Clinical
- Human factors validation completion
- Clinical performance summary (if applicable)
  Documents: Human factors report, validation data summary
Reimbursement
- Alignment of V&V outcomes to support cost-effectiveness arguments
  Documents: RWE synthesis for value message support
Medical Writing
- Support compilation of V&V evidence summaries for regulatory filing
  Documents: V&V narrative, software summary report for FDA/EU
Labs
- N/A unless wearable/implantable software is integrated with materials
  Documents: N/A

Regulatory
- Submission of clinical validation justifications or protocols (when required)
- Documentation alignment with MDCG 2020-1 (EU) and FDA guidance on SaMD
  Documents: Clinical protocol (if applicable), justification memo for literature/bench data
Quality
- Ensure traceability of clinical inputs to RMF and SDLC records
  Documents: Clinical-risk linkage analysis
Clinical
- Execution or oversight of human factors testing, performance validation, or literature review
  Documents: CER (EU), Clinical Evaluation Summary (US), SSCP (EU Class C/D)
Reimbursement
- Health economic model refinement
- Data generation aligned with payer priorities
  Documents: HEOR plan, payer evidence gap analysis
Medical Writing
- Clinical Study Reports, CER updates, Post-Market Clinical Follow-Up Plans (EU)
  Documents: CSR, CER, PMCF Plan
Labs (Jordi Labs)
- N/A unless clinical integration with device performance
  Documents: N/A

Regulatory
- Finalization of submission components (510(k), De Novo, MDR Tech File)
- Labeling and UDI content review
  Documents: Labeling packet, eSTAR checklist, EU GSPR table
Quality
- Completion of QMS documentation related to software production
- Software release documentation and cybersecurity deployment validation
  Documents: Finalized DHF, SOPs for release, software change control plan
Clinical
- Continued support for integrating usability and clinical performance outcomes into QMS
  Documents: Clinical evidence integration memo
Reimbursement
- Prepare value proposition materials for launch market access planning
  Documents: Reimbursement dossier, payer slide deck
Medical Writing
- IFU finalization, submission narratives, PMCF plan content
  Documents: Final IFU, PMCF Plan
Labs (Jordi Labs)
- N/A unless software controls hardware interaction in implantables
  Documents: Device-software interoperability report (if applicable)

Regulatory
- Complete 510(k), De Novo, PMA, or MDR Tech Doc preparation and submission
Response to AI/IR, RTA, Notified Body feedback
Documents: Entire regulatory submission packet, RTA checklist, NB response memos
Quality
- Support linking submission to QMS audit readiness
  Documents: Quality documentation list, audit support memo
Clinical
- Final submission of all clinical reports
  Documents: Clinical Summary, Clinical Evidence Table
Reimbursement
- Initiate payer submission strategy or clinical coding review
  Documents: Coding memo, payer outreach plan
Medical Writing
- Own authorship of submission content (intended use, clinical summary, labeling)
  Documents: FDA Summary of Safety and Effectiveness, EU Clinical Overview
Labs (Jordi Labs)
- Not typically involved unless integrated hardware
  Documents: N/A

Regulatory
- Marketing clearance communication, labeling compliance checks
  Documents: CE Certificate/510(k) letter, labeling confirmation report
Quality
- Software release to production documentation
  Documents: Final DHF, deployment SOPs
Clinical
- Launch evidence support and post-launch surveillance setup
  Documents: Post-market plan, user feedback protocol
Reimbursement
- Initiation of reimbursement submissions or coding applications
  Documents: Payer communication documents, CMS submission (if US)
Medical Writing
- PMCF implementation documents, launch messaging materials
  Documents: PMCF Report template, value-focused clinical brief
Labs
- Only applicable in hybrid wearable/implantable products
  Documents: N/A unless triggered by combination use

Regulatory
- Support for periodic updates (e.g., PSURs), vigilance reporting
  Documents: PSUR (EU), MDR vigilance reporting support
Quality
- Software change control documentation support
  Documents: Change justification memos, cybersecurity update logs
Clinical
- PMCF activities and registry/RWD support
  Documents: PMCF data reports, literature monitoring logs
Reimbursement
- Continued evidence generation for value-based care models
  Documents: Real-world outcomes tracking sheet
Medical Writing
- Periodic update support and narrative responses
  Documents: PSUR summary, client-facing safety narrative
Labs
- Not applicable

Regulatory
- Label expansions, software feature enhancements, international registrations
  Documents: Change notification documents, global submission strategies
Quality
- Validation support documentation for updates
  Documents: Validation summary support, QMS update documentation
Clinical
- Ongoing studies or new indication assessments
  Documents: Study protocols, evidence expansion map
Reimbursement
- Global payer engagement strategy for new markets
  Documents: Global reimbursement landscape
Medical Writing
- Authoring of regulatory justifications and updated submission components
  Documents: Clinical Addenda, Summary of Change Justification
Labs
- Not applicable

Regulatory
- Crisis response for recalls, MDR reporting, field corrective action
  Documents: Field Safety Notice, CAPA support documentation
Quality
- CAPA support, DHF remediation
  Documents: Root cause analysis, correction plan
Clinical
- RWE rescue studies or performance complaints
  Documents: Complaint analysis report
Reimbursement
- Evidence rebuttals or coverage challenges
  Documents: Appeals support packet
Medical Writing
- Urgent communications and supporting regulatory narratives
  Documents: Safety memo, regulator communication template
Labs
- Only if linked to physical component issue
  Documents: N/A unless combination

Flexible Partnering Solutions

Outsourcing

Customizable and scalable outsourcing scoped for entire projects, specific functions, or defined parts of a function. Leverage RQM+ expertise and flexibility while your teams stay focused on core competencies, corporate goals, and innovation. Partner with us.

Consulting

Targeted, outcome-focused expertise to solve defined MedTech challenges. RQM+
consultants step in with practical, actionable guidance and hands-on execution to drive timely resolution. Partner with us.

Staff Augmentation

Fill skill or capacity gaps with MedTech talent from RQM+. We provide on-demand
professionals, functional service support, fast deployment for tight timelines, and
contract-to-hire options that integrate seamlessly with your team. Match with a contractor.

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)