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.
Compliance requirements have risen sharply in recent years,
clinical trial, risk assessment or quality management system documentation. 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 - by 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.
Analyzes 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
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