From 2004-2015 (from 2002 to 2004 as a student), as a medical physicist, I dealt with quantitative and qualitative analyses of MR and TK images and I tested diagnostic devices at HELIMED Centrum Diagnostyki Obrazowej : HELIMED and at SCANiX. In the meantime,I conducted research at The University of Silesia in the field of solid state physics for the completion of my doctoral thesis in 2013.
Since 2015, I have been working in association with TUV NORD Polska (auditor, technical expert and lecturer for active medical devices). During the years 2013-2015, I attended postgraduate school in the field of health care management (formerly The University of Economics), ISO standards and quality management (AGH University of Science and Technology). Over the years 2015-2018, I developed my skills and knowledge as a Quality Manager and internal auditor at Silvermedia. I was responsible for certifying QMS, Technical Files for medical devices and I participated in the process of certifying the Telemedical Platform.
In 2019, I continued to focus on software as medical devices at Radpoint. In the same year, I started consulting in the area of QMS and Technical File for medical devices for companies like MIKROVOLT, MedApp, and SoftMed. Since October 2020, I have run my own business, Quality Power Magdalena Wicher, providing audits, training courses, implementations, and consultations in the range of QMS documentations, and Technical File for medical devices. Since May 2021, I have been honored to be one of the experts of AILAWTECH Foundation.
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Training courses:
1.The requirements of the ISO 9001 standard.
2.The requirements of the ISO 13485 standard.
3.Directive requirements 93/42/EWG.
4.Requirements of the new regulation for medical devices (MDR) 2017/745.
5.The requirements of the ISO 27001 standard.
6.The internal auditor based on the ISO 9001 standard.
7.The internal auditor and based on the ISO 13485 standard.
8.The internal auditor and based on the ISO 27001 standard.
9.Clinical evaluation for medical devices.
10. Application of usability engineering to medical devices based on the ISO 62366 standard.
11. Risk analysis according to the ISO 14971 standard.
12. Application of medical devices to URPL and Eudamed.
13. Quality Manager.
14.How to carry out management rewiev in your company.
16. Technical documentation for medical devices.
17. Preparing technical documentation for masks and protective medical suit as a medical devices.
18. Requirements 2016/425 in case of personal protective equipment.
19.Supervision of medical devices placed on the market according to 93/42/EWG and 2017/745 (MDR).
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Quality Managements (QM) Audits based on ISO: 9001, 13485, 27001, 27018 standards.
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Implementations of QM ISO: 9001, 13485, 27001, developing technical documentation for medical devices and ISO 14001:2015, ISO 45001, ISO 50001, PN-EN ISO/IEC 80079-34, IOS 22716, AQAP, complex OHS services, including OHS training course and fire training.
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Outsourcing of management representative for quality management and person responsible for regulatory compliance with article 15 of MDR (2017/745).
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Consultations and preparing documenation complied with ISO 14644 i ISO 14698 standard for CleanRoom.
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Design of medical devices
and others according to your needs.
SERVICES
Contact:
dr n.fiz. Magdalena Wicher
"Quality Power" Magdalena Wicher
NIP: 5472011953
Al. Bolesława Krzywoustego 4/1
Katowice 40-850,
tel: 602-586-810
e-mail: qualitypowermwicher@gmail.com
I invite you to cooperation
