Knowledge of regulatory requirements and strong business know-how are required for success in the field of health technology. This is our core competence: we take a comprehensive approach to the health tech field. We can support you in making choices that are sustainable in terms of regulation, business, product development and people.
We help your organization operate and develop according to requirements of the industry. Regarding health tech products, our service offering spans the whole product journey from an idea to market and post-market phase.
Our service offering consists of productized services, professional resources, coaching and training. We support actors of any size and type: public organizations, startups, companies transferring to health tech from other industries, research institutes and investors.
Read also more about possible funding instruments.
Quality and regulation
Success in the health tech field requires functional operational models that are compliant with regulation. Building a quality management system is an important requirement. Quality and regulatory work is broad and versatile: from us you can get turn-key quality management projects or coaching according to your needs.
Our services include the following
- Outsourced quality manager and PRRC-service
- Building a quality management system (ISO 13485)
- Risk management (ISO 14971)
- CE-mark, certification, and documentation
- Clinical evaluation and post-market data collection
Usability and service design
A successful product or service solution corresponds to needs of users, customers, and other stakeholder groups, and its design acknowledges business objectives. The solutions need to meet use safety requirements in the health tech field. The aim of product and service design is an effective, safe, and pleasant outcome.
You can contact us already when your product is on idea or concept level!
Our service offering consists of
- Concept design and testing
- Design sprint
- User experience (UX) design
- Formative and summative usability testing
- Support for usability process (IEC 62366)
Product development and processes
Well designed is half done in product development and commercialization of health tech innovations. You can ensure the success of your product, save time and control total expenses when the product development is done according to the health tech requirements and in co-operation with users from the very beginning.
We can support your team in different phases of product development process. We will walk all the way with you and make sure that your product can be CE-marked and certified.
Our offering covers the following topics
- Development of medical software life cycle processes (IEC 62304)
- Innovation process
- Product development consultation
- Technical realization of a product
Management support and business
Our aspiration is to promote awareness of health tech patient safety and operational principles for the benefit of various actors. Thus, we offer our expertise for developing successful business in the field of health tech.
We also help in finding suitable partners and subcontractors!
Our service offering consists of
- Business health check
- Business development, market research, sales support
- Management support: organization development and change management
- Product management and strategy
- People and expertise: professional resources for your needs