Products and Services
Our range of services covers everything required for the development, commercialisation and marketing of medical devices. Depending on your needs, we can provide ad hoc support, undertake clearly defined work packages or take overall responsibility for entire projects and products.
VR Framework & System Development
VR Framework & System Development
compliag AG’s VR framework forms the technical basis for the development of bespoke VR physiotherapy solutions. It provides the infrastructure on which new therapeutic applications can be built quickly, securely and in compliance with standards.
Features
- Modular system architecture for VR applications
- Standardised interfaces for handheld and controller integration
- Communication protocols for data transfer between the VR system and external devices
- Scalable platform for different indications and hardware
Scope of Services
- Provision and customisation of the framework to meet your product requirements
- Integration into existing systems or devices
- Technical documentation of the system architecture
- Support for expansion and maintenance
Benefits
- Reduced development time thanks to existing, tested infrastructure
- Reduced technical risk
- Flexible scalability for future therapeutic applications
Particularly suitable for manufacturers wishing to establish their own VR product range; research institutes requiring bespoke system integration.
Development of Therapy Worlds
Development of Therapy Worlds
We design and develop new, clinically validated VR therapy environments – from the initial concept through to the finished application, tailored to the specific indication and target group.
Features
- Interactive therapy scenarios for various conditions (e.g. balance, motor skills, cognition)
- Gamification elements to boost motivation and adherence to therapy
- Adaptive difficulty levels
- Progress visualisation for patients and practitioners
Scope of services
- Clinical co-design with therapists and end users
- Conceptualisation, prototyping and development of the therapy environment
- Usability and user testing
- Iterative refinement based on feedback
Benefits
- Higher adherence to therapy through motivating experiential environments
- Clinically tailored content rather than generic applications
- Differentiation through unique, brand-specific experiences
Particularly suitable for manufacturers wishing to expand their product portfolio to include digital therapeutic content; and research institutes developing and testing new interventions.
Regulatory documentation
Regulatory documentation
We produce the technical documentation required for the authorisation of VR medical devices.
Contents of the delivery
- Technical documentation in accordance with MDR requirements
- Risk management file
- Software lifecycle documentation (e.g. in accordance with IEC 62304)
- Fitness-for-purpose and usability documentation
Scope of services
- Analysis of existing documentation and identification of gaps
- Creation of comprehensive, audit-ready documentation packages
- Coordination with your quality management organisation
- Preparation for audits and Notified Body procedures
Benefits
- Reduced risk of delays in the authorisation process
- Consistent, standards-compliant documentation
- Reduced strain on internal resources
Particularly suitable for manufacturers without extensive in-house regulatory capacity; companies seeking approval for their medical device solution for the first time.
Authorisation in the EU and Switzerland
Authorisation in the EU and Switzerland
We guide you through the entire authorisation process for VR medical devices in the European Union and Switzerland.
Functionalities
- Classification of the product in accordance with the MDR or Swiss medical device legislation
- Conformity assessment procedures
- Coordination with Notified Bodies and regulatory authorities
- Market access strategy for the EU and Switzerland
Scope of services
- Advice on regulatory strategy
- Support throughout the conformity assessment procedure
- Communication with regulatory authorities and Notified Bodies
- Registration with EUDAMED and SWISSDAMED
- Allocation and management of UDI-DI
- Support with post-market requirements
Benefits
- A secure, predictable path to market authorisation
- Use of established processes rather than building from scratch
- Access to two key European markets
Particularly suitable for manufacturers with plans to enter the EU and/or Swiss markets; companies seeking to obtain authorisation for a VR medical device for the first time.
Import & Export
Import & Export
We can assist you with the regulatory and logistical requirements relating to cross-border trade in VR medical devices.
Features
- Checking import/export requirements for the EU and Switzerland
- Documentation for customs and trade processes
- Coordination with local authorised representatives (e.g. CH-REP, EU authorised representative)
- Advice on country-specific regulatory requirements
Scope of services
- Assessment of your current import/export processes
- Support in appointing authorised representatives
- Support with regulatory notifications
- Ongoing advice on market changes
Benefits
- Seamless cross-border market access
- Avoiding delays caused by missing documentation
- Certainty in the face of changing regulatory requirements
Particularly suitable for manufacturers with sales operations in several countries; companies wishing to enter new markets in the EU or Switzerland.
Device Management
Device Management
We manage and support your VR hardware throughout its entire product lifecycle.
Features
- Device inventory and management
- Software and firmware updates
- Maintenance and technical support
- Monitoring of device status and usage
Scope of Services
- Set-up of a device management system
- Ongoing technical support
- Coordination of maintenance and repair processes
- Reporting on equipment status and usage data
Benefits
- Reduced administrative burden for clinics and users
- Greater availability and reliability of equipment
- Transparency across the entire device fleet
Particularly suitable for manufacturers with large fleets of devices in the field; clinics and rehabilitation centres with multiple VR systems in use.
Clinical trials
Clinical trials
We plan and support clinical trials to assess the efficacy and safety of your VR solution.
Functionalities
- Study design and protocol development
- Ethics application
- Data management and statistical analysis
- Publication support
Scope of services
- Study design in consultation with clinical partners
- Conducting and monitoring the study
- Analysis and presentation of the results
- Support with publication and utilisation of the data
Benefits
- Robust clinical evidence for regulatory approval and commercialisation
- Stronger negotiating position with payers
- Scientific validation of your product claims
Particularly suitable for manufacturers requiring proof of efficacy for regulatory approval or reimbursement; research institutes with their own research interests.
Funding applications and capital
Funding applications and capital
We can help you identify and apply for suitable funding schemes for your VR innovation project.
Features
- Research into relevant funding schemes (national, EU, Switzerland)
- Assessment of your project’s eligibility for funding
- Preparation of funding applications
- Project management throughout the funding period
Scope of services
- Analysis of your project in terms of funding potential
- Drafting of the funding application, including budget and project planning
- Support throughout the application process
- Support with reporting and the use of funds
Benefits
- Additional sources of funding for innovation projects
- Reduced administrative burden thanks to expert support
- Higher success rate thanks to professionally drafted applications
Particularly suitable for manufacturers and research institutes with innovation projects in the field of VR medical devices; start-ups and spin-offs requiring funding.
Licensing & Commercialisation
Licensing & Commercialisation
We take existing research findings and prototypes and support their transfer into the commercial sector.
Functionalities
- Assessment of research results in terms of market potential and commercial viability
- Clarification of intellectual property (IP) rights and licensing models
- Transforming research prototypes into marketable, regulatory-compliant products
- Establishment of licensing and cooperation agreements between research institutes and industry partners
Scope of services
- Analysis and evaluation of existing research findings and prototypes
- Development of an exploitation and commercialisation strategy
- Negotiation and drafting of licence agreements
- Support with the development of a market-ready product
- Facilitation of collaboration between research institutes and industrial partners
Benefits
- Research findings reach the market rather than remaining unused
- A clear legal and economic framework for collaboration between research and industry
- Access to proven, scientifically sound innovations for manufacturers
- An additional source of commercialisation and revenue for research institutes
Particularly suitable for research institutes and universities with VR-related research findings seeking commercial exploitation; manufacturers looking for well-founded, research-based innovations.
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VR Framework & System Development
Technical infrastructure for VR development, including system architecture, handheld integration and communication interfaces, providing a solid foundation for bespoke solutions.
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Development of Therapy Worlds
Design and implementation of new, clinically validated VR therapy environments for physiotherapy and rehabilitation, tailored to your target group and clinical indication.
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Regulatory documentation
Preparation of the technical documentation required for the authorisation of VR medical devices – structured, comprehensive and compliant with regulatory requirements.
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Authorisation in the EU and Switzerland
Support throughout the entire authorisation process in the European Union and Switzerland, from classification to conformity assessment.
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Import & Export
Support with all regulatory and logistical requirements relating to the import and export of VR medical devices.
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Device Management
Management and support of the VR hardware deployed throughout its entire product life cycle.
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Clinical trials
Planning and conducting clinical trials to assess the efficacy and safety of your VR solution.
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Funding applications and capital
Support in identifying and applying for suitable funding schemes for your innovation project.
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Licensing & Commercialisation
Adoption of research findings and their transfer to industry.
Our areas of expertise
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Ganzheitliche Begleitung
Ein Partner für den gesamten Weg von der ersten Idee über die technische Entwicklung bis zur Zulassung und Markteinführung. Keine Schnittstellenverluste zwischen mehreren Dienstleistern. -
Regulatorische Sicherheit
Fundiertes Know-how in den Zulassungsanforderungen für Medizinprodukte in EU und CH reduziert Risiken und beschleunigt den Weg zur Marktreife. -
Klinischer Nachweis
Der Nachweis klinischer Wirksamkeit gehört für uns zum Tagesgeschäft und bildet die Grundlage für unsere therapiewirksamen Produkte. -
Schneller Marktzugang
Unser eigenes VR-Framework verkürzt Entwicklungszeiten und schafft eine stabile, erweiterbare Grundlage für neue Therapiewelten.
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Ganzheitliche Begleitung
Ein Partner für den gesamten Weg von der ersten Idee über die technische Entwicklung bis zur Zulassung und Markteinführung. Keine Schnittstellenverluste zwischen mehreren Dienstleistern.
-
Regulatorische Sicherheit
Fundiertes Know-how in den Zulassungsanforderungen für Medizinprodukte in EU und CH reduziert Risiken und beschleunigt den Weg zur Marktreife.
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Klinischer Nachweis
Der Nachweis klinischer Wirksamkeit gehört für uns zum Tagesgeschäft und bildet die Grundlage für unsere therapiewirksamen Produkte.
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Schneller Marktzugang
Unser eigenes VR-Framework verkürzt Entwicklungszeiten und schafft eine stabile, erweiterbare Grundlage für neue Therapiewelten.
Driving innovation
Do you have an interesting research project, or would you like to give your medical device a boost with VR or XR technologies? Get in touch with us – we’ll find a solution.