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on regulation
and reimbursement of medical devices.

Comprehensive technical and regulatory support for manufacturers, distributors, and other persons dealing with medical devices entering the market in reimbursements from public health insurance and in the development of the market of medical devices. Our long-term ambition is to be the most important consulting company in our field in the region of Central and Eastern Europe.

In recent years, requirements for regulatory compliance, clinical trials, risk assessment and quality management system documentation have increased dramatically. Porta Medica was established to fill the gap
in the market for consulting services specialized in the field of medical devices and offer manufacturers and distributors a high degree of specialization, substitutability, and practical experience in various fields.


The founders, Jakub Král and Aleš Martinovský, started building a team in early 2015 so that its members complement each other - with education
and practical experience. The current team of Porta Medica is represented by educated lawyers, biomedical engineers, ICT, and mechanical engineering graduates. The team members brought practical experience from the environment of multinational corporations, the Ministry of Health, the State Institute for Drug Control, and the academic sphere.

Strategic consulting

Analyze of the regulatory environment

Market and trade development consultancy

Strategies for moving the manufacturer to the new regulatory framework

Personnel consultancy in the regulatory area

Long-term support and expert advice to manufacturers, importers and distributors

Legislation of medical devices, medicines, food supplements, and personal protective equipment

Clinical evaluation, PMCF, and technical documentation of medical devices

Advertising regulation

Processing and communication of position documents, opinions, and opinions

Communication and PR support for specific projects

Newsletter Porta Medica (legislative monitoring) 12 xx per year


Conferences and seminars on current developments in legislation and practice

Specialized courses for regulatory experts of manufacturers, importers

Tailor-made training for the needs of corporate teams

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