The medical technology industry is one of the most innovative parts of the economy.

New products that help to save and prolong lives emerge almost every year. Bionics and implantation techniques are developing rapidly. Acquiring new contacts will enable MDR Regular and Pure Clinical to implement innovative products. We have unique experience in clinical research, regulatory, auditing, medical technology, as well as business management and marketing. Thanks to our knowledge and experience, we are able to efficiently launch a product on the EU market," added Katarzyna Wesolowska.

About Jagiellonian Innovation Center Company

The Jagiellonian Innovation Center Company was established in 2004 by Jagiellonian University in Krakow. Its mission is to build and manage the infrastructure of the Life Science Park, as well as to provide a broad set of services for entrepreneurs and scientists developing life sciences. Since 2013. JCI has been steadily expanding its offerings, most notably to include contract research services performed in the company's laboratories and clinical trials conducted in JCI's dedicated, specialized Clinical Research Center facility. "The Jagiellonian Innovation Center, in addition to its service and research activities in the field of medical devices, among others, serves as a Business Environment Institution. It is a place where technology companies and research teams can develop their products with the aim of launching them on the market. The combination of the market competencies of the MDR Regulator and Pure Clinical teams, together with JCI's scientific and research facilities, is beneficial not only for both Partners, but most importantly for potential contractors looking for a comprehensive offer on the market," said Dr. Anita Burkat-Dulak, Board Plenipotentiary for Innovation Projects.

Check information about EU Medical market ⚕️ MDR Regulator

June 14, 2023

MDR Regulator and Pure Clinical have established cooperation with the Clinical Research Center of the Jagiellonian Innovation Center

The Clinical Research Center of the Jagiellonian Innovation Center specializes in conducting clinical trials and carrying out complex research and development projects in the field of medicine and related sciences. The center cooperates with leading regional, national and foreign research centers located both in Western Europe and in the USA and Canada. “Our companies operate […]

June 14, 2023

The 4th National Scientific Conference – Polymers in Medicine is behind us

The conference was a good opportunity to exchange scientific experience in the wide application of natural and synthetic polymers in medicine, pharmacy and dentistry. The meeting was targeted primarily at academics – experienced researchers, as well as students, postgraduates and those working in the field of business practice. The lecture by Katarzyna Romaniszyn entitled: “From […]

June 13, 2023

New service – Authorized Representative (CH-REP, Swiss AR) in the Swiss market

Medical products that are sold outside the European Union must undergo conformity assessment procedures that differ from standards in the EU. MDR Regulator, together with its subcontractors, provides expert advice and support in obtaining permits and registrations in foreign markets. As of May 26, 2022, all manufacturers of medical devices and IVDs are treated the […]

May 12, 2023

MDR Regulator at Impact ’23

The two-day session included a panel entitled: “Diagnostic potential using new technologies/ Diagnostic potential using new technologies,” moderated by Katarzyna Wesołowska, CEO of MDR Regulator Sp. z o. o. and Board Member of Pure Clinical Sp. z o. o. The debate was attended by Piotr Węcławik, Director of Innovation at the Ministry of Health, Rafał […]

May 26, 2021

26 May 2021 – MDR is fully applicable today!

On 26 May 2021, the MDR has been fully applicable, following the transition period. If you are a Manufacturer, Importer or Distributor of medical devices, or have other responsibilities under the MDR, please make absolutely sure that you are a 100% ready for new obligations.

March 26, 2021

MDR requirements for custom-made medical devices

The Medical Devices Coordination Group (MDCG) established under Article 103 of Regulation (EU) 2017/745 published in March 2021 recommendations regarding the qualification of adaptable mass-produced medical devices, custom-made devices (CMD) and their components.

January 20, 2021

MDR and MDD Differences – what is going to change in May 2021

The new MDR Regulation (745/2017) compared to the current MDD (93/42/EEC) and AIMD (90/385/EEC) is much more extensive and detailed - it contains 123 articles and 17 annexes - which is more than 175 pages in total, compared to the 60-page Directive.

January 18, 2021

How BREXIT affects the export of medical devices to the UK?

From 1 January 2021, the United Kingdom is out of the customs union ,the single market of the European Union and ceased to be bound by EU law. Until the last few days, it was unclear how the UK's cooperation with the rest of the European Union would ultimately look. The Brexit deal creates regulatory barriers to trade in medical devices between the UK and the European Union.

July 24, 2020

MDR postponed for a year – how to plan the implementation stategy?

Regulation of the European Commission No. 745/2017 (MDR) significantly changed the requirements set out in the current Directives 93/42 / EEC and 90/985 / EEC was prepared for many years. After long expectations, in 2012 the first proposal for a Regulation was presented, which is much more restrictive than the applicable law. Therefore, many significant comments and proposals for the Regulation were made, so it lasted up to 5 years to publish the final version. Therefore it is not surprising, that companies and organizations in the medical industry have been worried by the fact about short implementation period of the new law.