KOSEK Agnieszka

3 declared company affiliations

Source: EUDAMED

Public regulatory data · synced 2026-08-05

20%

KOSEK Agnieszka is a Person Responsible for Regulatory Compliance (PRRC) in the medical device industry. Currently affiliated with Ekobiff Sp. z o.o.. Explore their full professional profile and affiliations on MD Atlas.

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Company affiliations

PRRC — Person Responsible for Regulatory Compliance
The PRRC is the qualified individual a manufacturer or authorised representative must have on hand to ensure ongoing regulatory compliance.
View in glossary →
Ensuring that: (a) the conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released; (b) the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date; (c) the post-market surveillance obligations are complied with in accordance with Article 10(10); (d) the reporting obligations referred to in Articles 87 to 91 are fulfilled; (e) Not applicable
Source: EUDAMED · non-removable
PRRC — Person Responsible for Regulatory Compliance
The PRRC is the qualified individual a manufacturer or authorised representative must have on hand to ensure ongoing regulatory compliance.
View in glossary →
Ensuring that: (a) the conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released; (b) the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date; (c) the post-market surveillance obligations are complied with in accordance with Article 10(10); (d) the reporting obligations referred to in Articles 87 to 91 are fulfilled; (e) Not applicable
Source: EUDAMED · non-removable
PRRC — Person Responsible for Regulatory Compliance
The PRRC is the qualified individual a manufacturer or authorised representative must have on hand to ensure ongoing regulatory compliance.
View in glossary →
Ensuring that: (a) the conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released; (b) the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date; (c) the post-market surveillance obligations are complied with in accordance with Article 10(10); (d) the reporting obligations referred to in Articles 87 to 91 are fulfilled; (e) Not applicable
Source: EUDAMED · non-removable

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Company affiliations

PRRC — Person Responsible for Regulatory Compliance
The PRRC is the qualified individual a manufacturer or authorised representative must have on hand to ensure ongoing regulatory compliance.
View in glossary →
Ensuring that: (a) the conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released; (b) the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date; (c) the post-market surveillance obligations are complied with in accordance with Article 10(10); (d) the reporting obligations referred to in Articles 87 to 91 are fulfilled; (e) Not applicable
Source: EUDAMED · non-removable
PRRC — Person Responsible for Regulatory Compliance
The PRRC is the qualified individual a manufacturer or authorised representative must have on hand to ensure ongoing regulatory compliance.
View in glossary →
Ensuring that: (a) the conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released; (b) the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date; (c) the post-market surveillance obligations are complied with in accordance with Article 10(10); (d) the reporting obligations referred to in Articles 87 to 91 are fulfilled; (e) Not applicable
Source: EUDAMED · non-removable
PRRC — Person Responsible for Regulatory Compliance
The PRRC is the qualified individual a manufacturer or authorised representative must have on hand to ensure ongoing regulatory compliance.
View in glossary →
Ensuring that: (a) the conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released; (b) the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date; (c) the post-market surveillance obligations are complied with in accordance with Article 10(10); (d) the reporting obligations referred to in Articles 87 to 91 are fulfilled; (e) Not applicable
Source: EUDAMED · non-removable

KOSEK Agnieszka

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