Experienced Consulting for Effective Medical Device & SaMD Development and Approval
DA | SV | EN

Medical Device and SaMD Consulting Services:

We provide senior consultants with decades of specialized MedTech experience—available for targeted advisory, peak-load sprints, or long-term interim roles tailored to your needs.

Explore examples of our consulting services below and reach out for an informal discussion.

Medical Device and SaMD Consulting Services:

Advisory in Compliance, Risk Management, Project Management, Quality, Standards & Audits

We tailor scope and delivery precisely to your organization:

  • Process Improvement: Defining and implementing lean, compliant product development processes
  • Project Management: Leading cross-functional regulated R&D projects
  • Quality Assurance: Right-sized quality balanced with engineering speed
  • Safety Risk Management, Cybersecurity Risk Management, Usability Engineering, AI Compliance & Supplier Audits
  • Product Development: Agile/Scrum & Lean medical development, Requirements & Systems Engineering
  • MDD, MDR, IVD, IVDR, ISO 13485, ISO 14971, FDA 21 CFR Part 820 / QMSR
  • IEC 62304, IEC 82304, IEC 62366-1, IEC 60601-1, EN 61010, IEC 80002-1, TIR57, TIR97, TIR45
  • CMMI, ISO 9000, ISO 9001, FDA, CE Marking
  • Internal and Supplier Audits across ISO 9001, ISO 13485, ISO 27001, IVDR, MDR, and MDSAP

Medical Device Consultants

Our team of risk managers, regulatory advisors, software architects, and project leaders can take ownership of isolated work packages or end-to-end compliance and product delivery:

  • Medical Device Software (Cloud, Server & Embedded): Reliable firmware and cloud architecture for regulated medical systems.
  • IoT Integration & Telemedicine: Remote patient monitoring, secure device connectivity, and medical cybersecurity.
  • Machine Learning & AI: Explainable clinical algorithms, diagnostic support, and predictive analytics.
  • Patient Monitoring Systems: Continuous vital-sign monitoring solutions across clinical and home environments.
  • Diagnostic Software: Medical imaging and clinical decision support software under EU MDR & FDA.

Workshops and Training

We also deliver practical team workshops and courses covering:

  • Medical software lifecycle compliance under IEC 62304, IEC 82304, and AAMI TIR45
  • Software Risk Management, Requirements Management,
    Security Architecture Patterns & Cybersecurity
  • Bringing your medical device to market and building audit-ready Technical Documentation

and other tailored regulatory topics at competitive rates.

Advisory Board & Due Diligence

Through decades of working with MedTech startups, accelerators, and investors, we provide objective regulatory maturity assessments and Advisory Board participation:

  • Organizational and technical readiness assessment for EU MDR, IVDR, and FDA
  • Ongoing Advisory Board support guiding founders from concept to market approval
  • Regulatory roadmap from clinical idea to certified Medical Device
  • Structuring lean QMS and Design Control capabilities
  • Technical and regulatory due diligence reviews

We apply a pragmatic, commercially grounded approach focused on de-risking regulatory milestones and maximizing investment value.

Examples of Specific Consulting & Advisory Engagements:

SaMD (Software as a Medical Device) Development

We navigate the complexity of Software as a Medical Device (SaMD) by combining modern software architecture, deep regulatory insight, and clinical focus—ensuring smooth compliance and market readiness.

Medical Device Development

We guide physical and connected Medical Device projects from concept through Design Controls, verification, validation, and global market launch.

AI in Medical Software Development

Specialized advisory in designing, validating, and documenting AI-enabled medical devices and SaMD under EU MDR, ISO 13485, IEC 62304, EU AI Act, and FDA guidelines—ensuring explainable, clinically robust algorithms.

Machine Learning and Compliance

End-to-end support across dataset governance, bias mitigation, model validation, risk management, and post-market performance monitoring with full QMS traceability.

EU MDR Consulting (Medical Device Regulation)

Pragmatic guidance through EU MDR (2017/745) classification, GSPR mapping, risk management, Clinical Evaluation, and audit-ready Technical Documentation.

IEC 62304 Consulting

Deep medical software lifecycle expertise aligning agile R&D workflows with IEC 62304 safety classes, SOUP management, verification, and configuration control.

ISO 13485 Consulting

Building, auditing, and training teams on lean, effective ISO 13485 Quality Management Systems tailored to your organization.

Risk Management & Audits

Establishing and auditing proactive ISO 14971 safety, usability, and cybersecurity risk management processes across the device lifecycle.

Test Automation for SaMD

Cost-effective, compliant test automation scaled to your software safety class—from CI/CD build pipelines and high-coverage unit tests to integration and system verification across cloud, Linux/Windows servers, and mobile platforms.

QMS Advisory

Gap analyses, process optimization, documentation support, internal audits, and ongoing maintenance for ISO 13485 and EU MDR QMS compliance.

External PRRC Services

Qualified external Person Responsible for Regulatory Compliance (PRRC) support under EU MDR/IVDR Article 15—ideal for micro and small MedTech companies seeking reliable regulatory governance.

AI Medical Compliance

Targeted regulatory strategy, algorithm validation, cybersecurity assessment, and CE-marking support that de-risks AI/ML medical products and accelerates time-to-market.