Who's who?

My name is Katarzyna Zofia Chrusciel and I'm the founder of MediQuasar Consulenza.

MediQuasar Consulenza is primarily oriented to the needs of the customers, who work with consultants from a various industries and fields.

MediQuasar Consulenza works with the people with rich expertise and knowledge of the medical devices and the cosmetic industry. Through our connections MediQuasar is able to solve the toughest problems that clients might present.

All our associates are Leader Specialists in their field. We pride in theoretical and education knowledge of the sector, as well as the practical skills acquired during work experience.

The brief summary of my CV:

Last year I've enrolled at the University of Bologna and I'm following the II Level Master degree course in Materials and sensor engineering for environmental sustainability. The program is entirely in English.(Planned completion in 2013).

In 2004 I completed graduate studies in Chemical Technology, the two-level five-year Master degree course in Chemical Technology, Materials for Management and Environmental Protection, Chemical Engineering at the AGH University of Science and Technology in Krakow, Faculty of Energy and Fuels. I got the title of Doctor of Science in Chemical Engineering.

Since 2009, I'm Quality Management System Lead Auditor. Through my work experience I had the opportunity to knew the Biomedical Industries "on job" and I carried out a variety of the audits for maintaining and obtaining the certification of the products (Medical Devices - UNI EN ISO 13485) and the quality systems (UNI EN ISO 9001 : 2008). My knowledge of the Legislative Decree 81/2008 and of the subsequent amendments (I'm the RSPP-Environmental Health And Safety Manager) gave me the fundaments for the management of the safety systems (OHSAS 18001).

With the experiences I acquired the following skills:

  • to make/prepare the Clinical Evaluation Based On The Literature, to extension of an existing clinical evaluation (if a device is already on the market) strictly developed to meet all of the requirements of the guide MEDDEV. 2.7.1;

  • to create the Cosmetic Product Safety Report with the research of the scientific articles;

  • to resolve the issues concerning the regulatory aspects of: classification of the specific type of the product, CE, marketing authorizations, import / export permits, verify the accuracy of labeling, compliance with the requirements of 'U.S. FDA 510 (k) Medical Device Submissions Requirements, preparation of the technical documentation for medical devices, etc.;

  • to know the requirements on Clinical Investigations laid out in annex VII of directive 90/385/EEC and in annex X of directive 93/42/EEC as amended by directive 2007/47/EC

  • to know the ISO 14155:2012 which describes the good clinical practice for the design, conduct, recording and reporting of clinical investigations.

  • to translate from Italian to Polish and from Polish to Italian:
    -translation of manuals and instruction manuals for equipment and machinery,
    -translation of safety procedures for chemical substances,
    -translation of clinical records, diagnostic and laboratory results, medical reports.