What we do
Our expertise
What we do
You built something that works. We build the evidence that gets it funded, approved and adopted. One team, the full pathway to market.
Market access & health economics
Payers do not buy technology. They buy proof that it saves money, time or lives. Quantified in the language they use, from budget impact to QALYs and quality of life. We build that proof: HTA to EU Regulation 2021/2282, decision-analytic models, budget impact analysis, evidence synthesis and business modelling.
Regulatory affairs
Medical devices and in-vitro diagnostics. A rejected technical file costs months you do not have, so we build files that pass: regulatory strategy and CE marking, technical documentation, ISO 13485 quality systems and cybersecurity compliance.
Beyond medtech
Compliance decides whether you launch in other fields too — food, functional and borderline products, and CBRN and defence programmes.
The whole path, not just your piece of it. Tell us where you want to go and you get a map of what still stands between you and the market.
OUR PROVIDED SERVICES
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Team Building Event 8-9 June 2026
On June 8, our entire team came together for a company-wide team-building event. The day started with a strong focus on work and collaboration, reinforcing the idea that business comes first before the fun begins. Throughout the day, colleagues worke...
News
Betthera Expands Its Services with CBRN and Defence Consulting
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News
Betthera Expands Its Services with Food Compliance
Betthera is pleased to introduce a new service focused on regulatory support for food products, functional products, and other emerging product categories. As regulatory requirements continue to evolve, companies face increasing challenges related to...
testimonials
Kind words
Betthera helped us with the preliminary planning of our QMS and technical documentation for our telemedicine platform for heart disease management and wellness applications.
CardioMedive
Our instituiton cooperated with company Betthera on project from Agency for Business and Innovation. Communication with the team was great and the project was successfully completed, we believe that new knowledge bring added value not only Bettheras customers but also for practice generally.
Vysoká škola technická a ekonomická v Českých Budějovicích
Betthera's commitment to excellence in usability analysis has significantly enhanced our product development journey. Their meticulous approach and attention to user experience have been invaluable. From the initial consultation to the final implementation, Betthera's team demonstrated a high level of professionalism and expertise.
The Imagination Factory
Our journey to market with Betthera at the helm of technical documentation and QMS setup was very effective. Their meticulous approach to preparing technical documentation ensured that every aspect of our product was thoroughly documented and compliant with industry standards. Betthera played a pivotal role in establishing a robust Quality Management System.
Carebot
Our collaboration with Betthera has been exceptional. Their expertise in regulatory strategy, usability analysis, and risk assessment is second to none. We also partnered on training workshops to enhance consortium members understanding in relation to all regulatory aspects of the project. We would recommend Betthera for comprehensive and effective regulatory support.
ENTERASENSE
We at Phage Glow greatly appreciate the expertise and professionalism of Betthera s.r.o. in conducting regulatory research for our entry into the South Korean cosmetics market. Their in-depth research and clear guidance on compliance requirements provided us with a solid foundation for future expansion. Their structured approach, attention to detail, and transparent communication made the entire process smooth and efficient. We highly recommend Betthera s.r.o. as a trusted partner for regulatory research and market entry preparation.
AUMED - PHAGE GLOW
I would like to express my gratitude to the Betthera team for their outstanding contributions as a partner of Horizon Europe project PAINLESS in the field of health economics. Their experience has been crucial to analyse the cost-effectiveness of palliative care services, which has derived in a publication and a current study. I also appreciate their expertise in health technology assessment and the reliability of all the staff.
Maria Teresa Carillo-de-la-Pena, Institute of Psychology (IPsiUS). Brain and Pain (BaP) Lab. Universidade de Santiago de Compostela, Spain. Lead Researcher of the EU funded PAINLESS Project.
Betthera provided us with outstanding MDR training — clear, practical, and delivered at the highest professional level. It significantly helped our teams better understand the regulatory requirements.
Prusa Research, a. s. - Vojtěch Tambor, Ph.D.
Betthera has been an outstanding partner in the NetZero AICT project. Their expertise in health economics and regulatory strategy has brought critical depth and structure to our work. They play a key role, their professionalism and strategic insight significantly strengthen the overall impact of the project.
NetZero AICT – professor Regent Lee
Cooperation with Betthera on the operational and economic analysis of the future multifunctional Hudečkova building for Prague 4 was highly professional. The analysis was prepared in a clear and structured manner, with a strong emphasis on the project’s realistic sustainability. Their expert approach and high-quality supporting materials made a significant contribution to informed decision-making regarding the project’s next steps.
Municipal District of Prague 4
...better therapies
...better assessments
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