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Opening
the EU Market to Your Medical Devices

Our Agency

Let's tackle regulatory affairs together.

We are Porta Medica, a Prague-based consultancy with a proven track record of supporting businesses in medical devices industry through results-driven regulatory consulting. We'll give your company the attention it deserves, offering personalized solutions and guidance to help you meet and surpass your goals.

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Tailored Solutions for Medical Device Industry Needs

At Porta Medica, we understand that each area of medicine and use case within the vast realm of medical devices comes with its distinct challenges and opportunities. Whether you are in manufacturing, distribution, healthcare services, whether you are regulatory expert or healthcare professional, our expertise and guidance are here to empower your success. Let's embark on a journey customized to your unique requirements.

Manufacturer

It is a tremendous privilege for medical device manufacturers to help save lives, heal and return people to active lives. The flip side of this privilege is the complexity of the business environment and demanding regulatory requirements, including requirements to demonstrate clinical benefit and deliver an acceptable benefit/risk ratio. We provide comprehensive regulatory support to medical device manufacturers with a focus on results. We realize that every innovative project, even one in the field of unmet clinical needs, must be commercially viable.

Distributor

Being in the field of distribution and import of medical devices seems very simple compared to the manufacturing of medical devices. It is not entirely true, because the distribution segment has its own specifics. These include good distribution practice, reimbursement of health care and reimbursement of medical devices from public health insurance, price regulation, regulation of advertising and others. Distributors of medical devices must appropriately combine knowledge from many of these areas of regulation while also having business excellence. Our support develops according to the needs and expectations of our clients: sometimes it is based on a project basis to solve specific business-regulatory tasks, sometimes it is a long-term business advisory.

IT Start-up

For a long time, we have been dedicated to supporting start-ups when entering the market of medical devices. Based on previous support to start-ups, we understand the mistakes, pitfalls and risks associated with newbies in the field of medical devices, sometimes combined with business juniority. We usually proceed from the definition of clinical benefit, through marketing consultations to guidance in the field of clinical evaluation. We offer start-ups project management in fulfilling regulatory obligations as well as securing a PRRC person. Special financial terms and conditions are a matter of course.

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"We have been working with Porta Medica for many years on a wide range of projects. The focus of our cooperation in the past period has been the new MDR regulation. Although Linet is a large company, the transition to the new MDR regulation has been a challenge and Porta Medica has been a good partner to enable us to meet this issue.


"As a member of the association that brings together all the major medical device manufacturers, I very much appreciate the proactive approach of Porta Medica to working with start-ups, small and medium-sized companies to help them with the complex processes involved in medical device regulation."

Tomáš Kolář

Connect with Our Experts

Let's tackle regulatory affairs together.

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