Development of Medical Software for VR, MR and XR Headsets
We develop applications for virtual reality headsets, mixed reality glasses, and smart glasses – ranging from simple health apps to medical devices approved under the MDR and FDA. Our ISO 13485 and ISO 27001 certifications guarantee the quality, security, and regulatory compliance of your software.
We develop for the entire range of Immersive Devices
From fully immersive VR headsets to lightweight smart glasses: We understand the regulatory, ergonomic, and technical nuances of each device category and work with you to select the right platform for your use case.
fully immersive
VR Headsets
Closed-headset systems with controller or hand tracking for fully virtual applications. Typical applications include digital therapies, pain management, exposure therapy, cognitive rehabilitation, and immersive simulations.
Sample Devices
Meta Quest 3 and 3S, PICO 4, HTC Vive Focus
fully immersive
VR Headsets
Closed-headset systems with controller or hand tracking for fully virtual applications. Typical applications include digital therapies, pain management, exposure therapy, cognitive rehabilitation, and immersive simulations.
Sample Devices
Meta Quest 3 and 3S, PICO 4, HTC Vive Focus
Mixed Reality
Mixed Reality and AR Headsets
Headsets mit Color-Passthrough oder transparenten Displays verbinden digitale Inhalte mit der realen Umgebung. Einsatzgebiete sind räumliche Datenvisualisierung, präoperative Planung, Navigation und hybride klinische Workflows.
Sample Devices
Apple Vision Pro, Meta Quest 3 (MR Mode), Magic Leap 2
Smart Glasses
Smart Glasses and AR Glasses
Lightweight glasses with a camera, audio, and an optional display. Used for hands-free documentation, voice-controlled workflows, teleconsultations, and displaying information in clinics.
Sample Devices
Ray-Ban Meta, XREAL, Even Realities
Smart Glasses
Smart Glasses and AR Glasses
Lightweight glasses with a camera, audio, and an optional display. Used for hands-free documentation, voice-controlled workflows, teleconsultations, and displaying information in clinics.
Sample Devices
Ray-Ban Meta, XREAL, Even Realities
End-to-End Implementation of Your XR Application
We offer you a comprehensive package of services covering software development, regulatory compliance, and information security — all from a single source. This helps you avoid coordination issues with external service providers and reduces the time it takes to bring your application to market.
Software Development
Concept development, UX design, and implementation of your XR application on the platform that best suits your needs. Mobile companion apps, web backends, data integration, and interfaces with clinical systems are, of course, included.
Information Security
Protection of sensitive health data in accordance with GDPR, HIPAA, and BSI requirements. Our ISO 27001 certification, penetration tests, and an established information security management system (ISMS) form the foundation.
Technical Documentation (MDR & FDA)
Preparation of all technical documentation in accordance with IEC 62304 (Software Life Cycle), ISO 14971 (Risk Management), and IEC 62366 (Usability Engineering), as well as the Design History File (DHF), Device Master Record (DMR), and Device History Record (DHR) for the FDA submission.
Regulatory Consulting
Classification of your application as a medical device, selection of the appropriate approval pathway (MDR conformity assessment procedure, FDA 510(k), De Novo, or PMA), preparation for and support during audits, and, upon request, assuming the role of marketing authorization holder.
Applications in the Medical Field
Immersive technologies are used in nearly all clinical and therapeutic areas. The following fields represent a selection of typical use cases that bring customers to us
Therapie and Behavioral Health
Digital therapies for anxiety disorders, phobias, chronic pain, depression, or substance use disorders. VR-based digital health applications (DiGA) are already listed in the BfArM directory, and in the U.S., there are FDA-authorized VR therapies such as RelieVRx.
Surgery and Surgical Navigation
Overlaying CT and MRI data directly in the surgeon’s field of view, preoperative 3D planning, and intraoperative navigation. Examples on the market include Augmedics xvision for spinal surgery and Brainlab Spine Mixed Reality Navigation.
Diagnostics and Medical Imaging
Stereoscopic 3D visualization of radiological data, spatial diagnosis, and cardiac and vascular imaging. Radiology is by far the largest field of application on the current FDA list of approved AR and VR medical devices.
Medical Training and Simulation
Realistic training environments for surgical procedures, emergency scenarios, nursing education, and patient education. Reduces the costs, risks, and logistical challenges associated with traditional simulations.
Rehabilitation
Exercise- and tracking-based rehabilitation following a stroke, brain injury, or orthopedic surgery. Gamification elements increase adherence to therapy and motivation.
Telemedicine and Remote Care
Remote consultations, joint assessments across distances, and at-home therapy sessions with support from therapists or clinical teams.
What makes us special
ISO 13485 certified
Our quality management system is certified according to ISO 13485. This enables us to ensure the compliant development of software as a medical device and to meet the requirements of the MDR and FDA (21 CFR) for quality management systems.
ISO 27001 certified
QuickBird Medical is ISO 27001 certified for information security. We are experts in cybersecurity and in handling sensitive health data in compliance with data protection regulations.
External placing on the market
If required, we can serve as the legal manufacturer for your medical device software. We will therefore assume legal responsibility for compliance with all regulatory requirements of the MDR or the FDA. This allows you to focus on your core competencies, such as sales and marketing.
Platform-agnostic and Future-proof
We develop on the leading XR platforms and SDKs. The right platform for your project depends on your target devices, performance requirements, hardware strategy, and distribution channels. We provide vendor-neutral advice.
Unity
Unreal
OpenXR
Apple visionOS
Meta Horizon OS
AndroidXR
WebXR
Our Process: From Concept to Approval
1. Conception
We will work with you to define the medical use case, the target platform, and the regulatory classification. We will assess whether and in which risk class your application should be classified as a medical device, and which standards apply.
2. Planning
We create the initial technical documentation, define the development process in accordance with IEC 62304, plan verification and validation activities, and define the software architecture for your application.
3. Software Development and Documentation
We develop your application in agile sprints, document it in the quality management system as we go, and ensure the traceability of all requirements. You’ll receive regular, usable interim results.
4. Verification and Validation
We systematically test your application against all technical, clinical, and ergonomic requirements, ranging from automated tests to usability studies and clinical evaluation.
5. Approval as Medical Device
We prepare all documentation required for the MDR Declaration of Conformity with CE marking as well as for the FDA submission, and guide you through the Notified Body audit.
6. After Approval
We support you with post-market surveillance, vigilance reports, software updates, lifecycle management and expansion into new markets.
Are you Planning to Develop a Medical XR Application?
Our team will handle the software development for your VR, MR, or XR application. You’ll benefit from our experience in implementing all regulatory requirements of the MDR and FDA. Contact us to schedule a no-obligation initial meeting. Let’s work together to find out how we can help you with your project.