Medical Device Quality Manager

A graduate of the University of Gdańsk, Faculty of Economics. She is a certified management systems auditor, business consultant, certified trainer, and academic lecturer with extensive professional experience.

Since 2005, she has served as a management systems auditor in accordance with the following standards: ISO 9001, ISO 14001, ISO 27001, WSK AQAP 2110, and SPZK. Since 2019, she has been associated with CeCert, acting as an authorised representative and decision-maker in management system certification processes as well as in personnel certification.

She has significant training experience, having delivered numerous courses and workshops on topics such as lead auditor training, internal auditing, and standard requirements.

President of the Management Board, CeCert Sp. z o.o.

A graduate of the Faculty of Management at the University of Warsaw, holding a PhD in Economics with a specialisation in Management Sciences.
President of the Management Board of CeCert Sp. z o.o., he has been involved in the certification industry since 2014.

During this time, he served as a member of Technical Committee No. 6 – Management Systems, operating under the Polish Committee for Standardisation. He has also been a member of the Chapter of the Polish Quality Award (KIG) and the Foundation of the Polish Promotional Emblem "Teraz Polska". He has represented the national certification body within IQNet, IECEE, and EOQ structures.

He holds auditor qualifications for ISO 9001 and ISO 13485 standards. He has been closely involved in the field of medical devices, both through his work in certification and as the Chief Operating Officer of Warszawskie Zakłady Sprzętu Ortopedycznego S.A. – a manufacturer of Class I medical devices.

A licensed medical laboratory diagnostician and graduate of the Medical University of Warsaw with a degree in Medical Analytics. He gained his knowledge and professional experience while working as a specialist in the Department of Medical Devices Supervision and Clinical Investigations at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPL). For five years, he was responsible for supervising the Polish market of in vitro diagnostic medical devices (IVDs).

He has been an active member of working and expert groups on IVDs operating under the European Commission. As a trainer, he also participated in a Polish–Lithuanian twinning programme for the Moldovan Medicines and Medical Devices Agency, aimed at aligning Moldova’s regulatory system for medicinal products and medical devices with European Union legislation and standards.

As a specialist and expert at the Polish Centre for Testing and Certification (PCBC), he was responsible for conducting certification processes and evaluating the technical documentation of IVD devices manufactured by both Polish and international companies.

He is a lead auditor of quality management systems compliant with the EN ISO 13485 standard. He has been a long-standing representative of URPL, PCBC, and CeCert on the Polish Committee for Standardization (PKN) Technical Committee No. 300 for In Vitro Medical Laboratory Testing.

After joining CeCert as Director of the In Vitro Diagnostic Medical Devices Certification Department, he was personally responsible for leading the authorisation process that resulted in the company being designated as a notified body under Directive 98/79/EC. The process concluded successfully, and on 2 January 2022, CeCert was listed in the European NANDO database as Notified Body No. 2934 – becoming the second in Poland and only the nineteenth in the EU authorised to issue conformity certificates for all categories of IVD medical devices subject to mandatory certification.

A graduate of the Faculty of Chemistry at Lodz University of Technology with a degree in Nanotechnology, specialising in functional nanomaterials. She pursued doctoral studies in the field of Radiation Chemistry of Polymers at the same faculty, while also completing postgraduate studies at AGH University of Science and Technology in Kraków in Biomaterials – Materials for Medicine.

An enthusiast of research and development in polymer technologies for medical applications, she has led numerous research projects in this area, funded by institutions such as the National Science Centre. She is the author of several scientific publications on biomaterials and radiation-modified biopolymers, and a recipient of numerous awards, including the scientific award granted by the International Irradiation Association (IIA) for her work on the radiation modification of polysaccharides for medical use.

She has applied her expert knowledge in professional settings for many years, initially as a specialist in the assessment of medical device sterilisation. She then gained further experience at the Polish Centre for Testing and Certification (PCBC S.A.), working as a medical device certification specialist responsible for conducting certification processes under Council Directive 93/42/EEC (MDD), later becoming the head of the entire team.

Since 2023, she has been with CeCert Sp. z o.o. as Deputy Director of the Medical Device Certification Department, where she is responsible for preparing the organisation for the notification process under Regulation (EU) 2017/745 on medical devices (MDR).

She is a long-standing member of the Polish Society for Radiation Research and the Polish Society for Biomaterials. She has represented PCBC S.A., and subsequently CeCert, on the Polish Committee for Standardization (PKN) Technical Committees:

• Committee No. 295 – Sterilisation

• Committee No. 247 – Medical Materials and Biomaterials

She is an experienced lead and technical auditor in conformity assessment of medical devices under both the MDD and MDR, as well as quality management system audits under ISO 13485:2016. She has participated in or led over 50 audits of medical device manufacturers in Poland and abroad.

A nanotechnology engineer and graduate of the Faculty of Chemistry at Lodz University of Technology. He further enhanced his qualifications by completing postgraduate studies at AGH University of Science and Technology in Kraków, specialising in Biomaterials – Materials for Medicine.

From the beginning of his career, he has been closely associated with the medical device industry. He initially worked as an R&D and Quality Control Specialist at a manufacturer of high-risk medical devices, including wound care products and implantable devices.

He later joined a notified body, PCBC S.A., where he held the position of Senior Specialist for Medical Device Certification. Since 2021, he has served as the Director of the Medical Device Certification Department at CeCert Sp. z o.o., where he is personally responsible for coordinating the company’s notification process under Regulation (EU) 2017/745 on medical devices (MDR).

He is a long-standing member of the Polish Society for Biomaterials and has represented both PCBC and CeCert on various Polish Committee for Standardization (PKN) Technical Committees, including:

• Committee No. 295 – Sterilisation

• Committee No. 247 – Medical Materials and Biomaterials

• Committee No. 284 – Mechanical Medical Equipment, Tools and Devices

He also serves as CeCert’s delegate to Team NB – The European Association of Medical devices Notified Bodies.

An experienced and active auditor, he performs both lead and technical auditor roles for audits assessing conformity with the Medical Devices Directive (MDD) and Medical Device Regulation (MDR), as well as audits of quality management systems for medical devices under ISO 13485:2016.

He is also a long-time trainer in the field of preclinical testing of medical devices in accordance with the PN-EN ISO 10993 series – Biological Evaluation of Medical Devices.

A graduate of the Medical University of Białystok with a degree in Medical Analytics, and a licensed Medical Laboratory Scientist by profession. She began her professional career in laboratories at the District Sanitary and Epidemiological Station and the Polish Stem Cell Bank, where she gained hands-on experience with in vitro diagnostic medical devices through daily use.

She expanded her regulatory knowledge while working at the Polish Centre for Testing and Certification as a Senior Specialist in the certification of in vitro diagnostic medical devices, where she was responsible for managing certification processes and evaluating clients’ technical documentation. During this time, she also served as a representative on the Technical Committee for In Vitro Medical Laboratory Testing at the Polish Committee for Standardization (PKN).

A medical biotechnology graduate and certified pharmaceutical technician. She has over 10 years of experience in the regulatory field related to medical devices, including work at the competent authority (URPL) and in notified bodies.

She is a lead auditor in the conformity assessment of IVDs, MDs, and ISO 13485 standard, having conducted over 60 audits of both domestic and international manufacturers. She serves as an IVDR trainer at CeCert, project leader, and decision-maker in CE certification processes for IVD devices. She is also responsible for reviewing and evaluating technical documentation.

In addition, she has extensive experience working with numerous experts and acts as a technical documentation evaluator and conformity assessment specialist for medical devices.