Consulting
We support healthcare innovators across research, development, integration, AI, and regulatory compliance. As experienced medical imaging and MedTech professionals, we complement your team with specialized expertise, proven technology, and practical industry insights.
- Research & development
- AI development
- Regulatory services
- Custom integration
- Commercialization & post-market support
Core expertise
Built on years of experience in medical imaging, computer vision, and image-guided interventions, our team delivers proven solutions for complex technical and clinical challenges by combining diverse expertises.
- Endoscopic vision
- Ultrasound processing
- X-ray & CT reconstruction
- Machine learning
- Multi-model image fusion / registration
- Computational anatomy
- Real-time streaming
- Robotics assisted workflows
- Surgical guidance & navigation
Clinical applications
Across clinical specialties, we connect patient-specific planning with intraoperative imaging, navigation, and robotics. Our platform allows us to reuse proven components and quickly adapt them to new clinical needs. If your application is not yet on our list, get in touch and help us make the list longer.
- Abdominal procedures
- Cardiac procedures
- Endoscopic surgery
- Neuro-imaging and surgery
- Orthopaedics & MSK
- Prostate interventions
- Spinal surgery
- Vascular procedures
See how teams take medical imaging from prototype to cleared product
Enabling image guidance for incisionless tumor treatmentImFusion combined advanced imaging research with scalable software architecture to help bring a novel oncology platform from preclinical development to commercial release.
Developing a robotic spine surgery platformFor robotic spine surgery, the ImFusion Suite and SDK combined image registration, anatomical analysis, planning, and 3D visualization to connect patient imaging with navigation and robotic guidance.Frequently Asked Questions
Can ImFusion provide technical documentation for regulatory submissions?
Yes. We deliver comprehensive technical documentation aligned with IEC 62304, ISO 13485, and ISO 14971 standards. This includes user and software requirements, risk analysis, verification reports, cybersecurity assessments, and full traceability matrices — ready for CE marking or FDA submissions.
Are your development processes compliant with ISO 13485?
Absolutely. Our quality management system has been certified to EN ISO 13485:2016 since 2016 and undergoes annual audits. All software development activities follow clearly defined SOPs, including risk management, configuration control, and document versioning.
Can you assist with cybersecurity?
We conduct cybersecurity risk analyses for software developed by using the STRIDE model and prepare documentation that meets IEC 81001-5-1, MDR Annex I, and FDA cybersecurity guidance. This includes risk mitigation strategies, data flow analysis, and support for secure software design.
What documentation do you provide for your AI-powered medical software?
For AI-powered medical software, we supply model reports detailing architecture, training datasets, performance metrics (e.g. accuracy, F1 score), and limitations. These documents align with EU AI Act guidance and FDA recommendations for SaMD.
What is ImFusion’s role in the post-market phase?
While the manufacturer retains full regulatory responsibility, we support post-market surveillance activities such as bug tracking, risk re-evaluation, and maintenance documentation updates. We also update traceability links if software is modified post-deployment.
Discuss your imaging goals, and constraints, then outline a clear path from concept to delivery.
Discovery Call
In a discovery call, we learn about your clinical or technical challenge and discuss how ImFusion’s expertise and technology could help make your idea a reality. Together, we identify promising first steps and determine where we can add the most value.
- Identify technical risks and regulatory considerations early
- Align engineering, clinical, and business stakeholders quickly
- Get a realistic timeline and resource estimate
- Leave with actionable next steps, not vague promises