Company Profile 3 R's FOR YOUR SUCCESS R&D - REGISTRATION - REALISATION 20 years of operational experience tell us: Innovative ideas and specialised knowledge alone are no guarantee for a successful business. 1. Company-, technology- and product assessments A good understanding of the technology and the potential of your company is important for a successful investment. Assessment of product potentials Definition of the USP Risk assessments Business plans and Due Diligence Search for project and financial partners 2. Risk analysis and risk management DIN EN ISO 14971 For your medical device we carry out risk analyses and develop research and development plans to minimise risks. Analysis and review of development and registration risks Analysis and review of market risks Risk mitigation measures Integration of DIN EN ISO 14971 into your development process 3. R&D concepts and product developments MDD 93/42/EEC We develop with you R&D concepts to address market and registration requirements. R&D concepts Analysis and management of development risks Planning and implementing target-oriented processes Planning clinical evaluations 4. Conformity assessment and CE mark With our know-how the CE mark is a realistic objective and no hurdle to marketing your product. Conformity assessment route CE mark submission Coordination with Notified Body and national authorities 5. Marketing and market access We help you to successfully market your product on the basis of our experience and extensive network of partners, distributors, customers and payers. Product and Customer specific market analyses Market entry strategies 6. Quality Management Systems DIN EN ISO 13485 Design and optimisation of your QM-System according to DIN EN ISO 13485 for medical devices 7. Change and company growth We assist change process and company growth by integrating new strategic objectives into operational processes and structures. Analysis of existing process- and structures Management Coaching Conflict and change management 8. Interim management By utilising our competencies and capacities in interim management projects you overcome bottlenecks and objectives can be achieved in time. We support you as project manager or member of the executive team for a defined period of time.