Regulatory affairs and economic and social impact of medical technologies
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What we do

Our expertise

We calculate the economic efficiency and evaluate the effectiveness of investment in chosen areas of healthcare and emerging technologies. We provide the valuation of the proposed solutions in the context of economic, social, demographic and quality of life (QALY) aspects. Our strategic assessments provide analysis and critical insights for the development and implementation of effective business decisions. We help realistically assess the financial, technological and social aspects. The multifactorial evaluation determines the technical possibilities and market potential of the innovation with objective analysis, data interpretation and insights. In regulatory affairs, we perform a gap analysis of our client's regulatory strategy. We set and design the individual steps, including the necessary tests and verifications, which are necessary for a successful medical device conformity assessment process.
HEALTH ECONOMICS
ECONOMIC EVALUATION OF MEDICAL DEVICES
REGULATORY AFFAIRS
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Betthera awarded a project on health economics data collection and sorting
Thanks to European Regional Development Fund (ERDF) fund Betthera has started the development of its proprietary know-how database, which will significantly improve our service and will serve to large number of clients in the future. The notice ...
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Regulatory Affairs as a new service
Together with new competencies and experience of our enlarged team, we support the set up of a robust quality management system (QMS) complying the regulatory requirements in the field of medical devices. Our clients will decide, which form of suppor...
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Betthera selected as Health Economics partner in EU Horizon projects
Betthera recently participated to several EU Horizon proposals as a Health Economics and / or Regulatory partner. This included proposals in neuromodulation of pain, in gastroenterology diagnostics by smart capsules, rare diseases, life style and men...
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testimonials
Kind words
Betthera supported us with setting up an appropriate Index for our product, according to which we will adjust its price over the next years.
CHEMPROTECT
Betthera evaluates marketability of our custom-made non-active functional implants which brought us key information for further decisions and provided us conslutation in regulatory area.
Biomedical Engineering
Through network analysis we have received management insides on important relationships outside of established hierarchy.
AMIRES
Betthera performs a qualitative and quantitative evaluation of the impact of our innovative dental products adoption in the clinical practise.
Denten - Dental Engineering
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