To make it in health technology, you need to be familiar with the regulatory requirements and the specifics of the industry. That is our core competence. We offer productized services, senior adviser resources, coaching and training for actors of any size and type: large public organizations, innovative startups, companies migrating to health tech from other industries, research institutes and investors.
From innovation to product
When it comes to commercializing health tech innovations, well planned really is half done! You can ensure your product’s success, save time and keep total costs under control if you take industry requirements into account and involve end users from the very start. You can contact us early on, even at the idea generation or concept development phase.
We can also help you find the right partners and contractors from our network.
We offer our expertise e.g. in the following steps:
Design and evaluation
- Service or product conceptualization
- Agile product design strategy
- Co-design methods, e.g. design sprint, user story mapping
- Concept evaluation, formative and summative usability testing
- User and market studies
- Business model and product strategy design
- User experience (UX) design
- Software architecture design
- Feasibility assessment
- Technology review
Risk management and clinical testing
- Definition of intended use of the product
- Definition of medical device class and risk category
- Patient risk analysis
- Preparation of clinical testing
Quality, product development and CE mark
To succeed in the health tech market, your operations need to run smoothly. For manufacturers of CE marked products or other actors in the delivery chain, the first requirement is a quality management system (QMS). Using our project model based on ISO 13485 requirements, we can build a QMS for large organizations and small startups. How to divide the work depends on your needs: do you prefer a turn-key project or an adviser to consult?
In a product development project, we support and coach your team through the process. We can also help to implement the planned operational changes. We’ll walk with you to the finish line and make sure your product has what’s required for CE marking and certification.
We offer support and coaching e.g. for the following needs:
- Setting up a Quality Management System (ISO 13485)
- Developing risk management (ISO 14971)
- Developing software life cycle processes (IEC 62304)
- Usability engineering process (IEC 62366)
- Clinical evaluation and post-market-data collection
- Product development support, e.g. documentation and audits
- Organizational development and support for change management and leadership
People and expertise
We offer our experience and know-how for your benefit! You can make big things even with small resources with the help of expert advisers. Our Quality Manager Service is a cost-effective way to take care of regulatory requirements and communication with authorities. From our extensive network, we can find you experts for even very highly specialized areas of expertise.
We arrange extensive training programs or targeted courses on specific topics to support expertise in your organization. See up-to-date details on our Training page.
We support the development of expertise in your organization e.g. with the following services:
- Quality Manager (PRRC) as required by Medical Device Directive (EU 2017/745, MDR)
- Coaching for your Quality Manager
- Quality Manager Accelerator training program
- Product-related training: usability engineering, user experience and user-centered design process
- Targeted senior advisers for a project or a specialty
- Advisers for short-term needs e.g. related to personnel changes
- Commercialization of new innovative product: support for sales initiation
- Product portfolio management
We can help you to identify bottlenecks and critical areas of development for your business and product. We review operational models and guidelines, compile a report of strengths and areas to develop and present suggestions for development in priority order.
Health check is designed for
- Organizations involved in the life cycle of medical devices or software
- Industry newcomers
- Investors requiring more information about a company’s status
- Research institutes and universities wishing to commercialize research results
We can review the following topics:
- Development of critical regulatory areas, e.g. Medical Device Regulation (MDR, EU 2017/745) In Vitro Diagnostic Regulation (IVDR, EU 2017/746) and General Data Protection Regulation (GDPR, EU 2016/679)
- Local regulations in a single European country or other main market area (e. g. USA, FDA)
- Risk management with patient safety focus
- Market specifics in a single country
- Critical business areas with competitiveness focus
- Obstacles for business and sales
- User experience and risk regarding a product or a service