Medical Devices - Supplements - Cosmetics

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  Contact : Tel. +39 053598377 Cell. +39 3404873873

Our Team

Katarzyna Zofia Chrusciel

Name Chrusciel Katarzyna Zofia
Designation CER Author & Evaluator
Experience: 10 Years
Education: Doctor Engineer
Profile:

 

  • Preparation and review of clinical data analysis and Reports
  • Implement and monitor effectiveness of clinical evaluation plan and risk Management activities
  • To search the related literatures on internet. Review literatures and make Clinical evaluation report based on literature review
  • To identify training needs and ensure continuous training of employees on Aspects of clinical evaluation and risk management.
  • To work with the design team and participate in product change control Activities.
  • To identify and implementing statistics and product improvement tools
  • To review risk management based on Clinical data
  • Analysis of clinical evaluation, customer complaint and process results
  • To ensure that documents generated from clinical studies meet all applicable regulatory requirements.
  • 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 REV.0.4;
  • 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 design, conduct, recording and reporting of clinical investigations;
  • To give consultancy about the product technical documentation  necessary to comply with Directive 93/42/EEC and subsequent amendments;
  • To create the documentation about medical devices given by the manufacturer to the user (labels and instructions for use);
  • To provide support in regards to Risk Management process as well as writing, with shared responsibility, of the Plan Risk Management;
  • To provide support with the risk analysis and the Risk Management Report, according to the standard EN ISO 14971;
  • Planning & validation Steam and EO Sterilization, etc
  • Implementation & Monitoring of Change control management
  • Implementation of Statistical Process Control in the process
  • To resove 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 implement the quality certification systems according to the standards EN ISO 9001, EN ISO 13485 as well as the implementation of company management systems based on organization, resource development and management technique application (Analysis of service supply processes; Quality Manual writing; Procedure Writing; Audit; Specific Training;
  • To provide support during the Management Review, for obtaining quality certifications and to maintain and improve the acquired system.
Specialized training

Cochrane 2017

Introduction to conducting systematic reviews

Writing the review protocol

Searching for studies

Selecting studies and collecting data

Introduction to study quality and risk of bias

Analysing the data

Materials and sensor engineering for environmental sustainability  2011 Studied subjects at University of Bologna: materials characterization and laboratory, science and technology of composite materials, polymeric materials, photocatalytic processes and environmental applications, physical chemistry for nanotechnology , inorganic chemistry for nanotechnology, solid state chemistry and laboratory, wireless sensor networks, biomedical transducers, fundamental chemistry of solids, industrial catalysis, physical chemistry of coal, physical chemistry of surface phenomena, physical chemistry of modern materials, computational methods in chemistry and chemical technology, instrumental methods of analysis of environmental pollutants, purìfication of gases – methods and equipment [project], energy raw materials and their processes, technological placement
Quality Management System Lead Auditor 2009 Since 2009, I’m Quality Management System Lead Auditor. Through my work experience I had the opportunity to get to know the Biomedical Industries “on site” and I carried out a variety of the audits for maintaining and obtaining 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).
Chemical Engineering  1999 – 2004

 

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.
CER  Related Experience: non-invasive devices included in class I, disinfectants for medical devices (Quaternary ammoni), Dental implants, pins, drills, external fixators, bone screws, reusable instrumentation, catheters (various types), Single use gloves, anti-mite and anti-decubitus products (mats, cushions, fabrics), sterile and non-sterile pessary, buccal pad for self-collection, sterile cervical brushes, sterile padded swabs, sterile swabs with transport medium, sterile swabs without transport medium, toothbrushes for cytological collection, etc., ophthalmic and oral solutions, patient radiology kit, medication kit, etc., containers with lid for heat-sealing for samples, DM, CO2, etc. spirometry mixtures, sterile sheaths for endoscopy, Implantable polypropylene mesh, tracheo set,  uterine manipulator, dental cements, surgical invasives, medical beds, containers for the transport of antiblastic drugs, urine bags, pliers, clamps, set catheterization, emptying bags, device indicated to simplify the application of granular biomaterial directly in the surgical site, a single-use set designed to infuse uniformly and homogeneous porous biomaterials with sterile saline solution, etc