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GXP is a reliable regulatory partner for success of your company on the market of medical devices.

We provide comprehensive services of:

The Authorized Representative for manufacturers non-residents of the European Union

- Preparation of Delegation (Service) agreement- Preparation of Power of Attorney
- Executing functions of the Authorized Representative in EU according to requirements of MDR Regulation (EU) 2017/745 on medical devices and IVDR Regulation (EU) 2017/746 on in vitro diagnostic medical devices)

Certification and marketing of medical devices (MD) and in vitro diagnostic medical devices (IVD)

- Conformity assessment support
- Preparation and maintenance of technical documentation (technical file) according to the requirements of MDR Regulation (EU) 2017/745 on medical devices and IVDR Regulation (EU) 2017/746 on in vitro diagnostic medical devices);
- Preparation of Declaration of conformity;
- Preparation of Risk analysis;
- Individual approach;
- Involvement of experts according to peculiarities of devices;
- Communication with a chosen Conformity Assessment Body;
- Recommendations on choosing a conformity assessment procedure;
- Recommendations concerning labeling and instructions for use;
- Result of our work is a conformity assessment certificate
- Assistance in choosing of subcontracting organizations for realization of non-clinical investigations, clinical investigations concerning determination of an expiry date, processes’ validation, etc.
- Development of a labeling and instruction for use;

Development, implementation and certification of quality management system according to EN ISO 13485:2016

- Pre-certification audit of the manufacturing site by a qualified expert;
- Preparation of a report, recommendations and a QMS implementation plan;
- Composition of a quality guideline, risk analysis etc.
- QMS implementation on the manufacturing site, maintenance of records, training of personnel, internal audit
- Support of a QMS certification procedure in a chosen Certification body;
- Result of our work is a Certificate of conformity to requirements of EN ISO 13485:2016

Consulting services concerning labeling of medical devices:

- Labeling project development following requirements of EN ISO 15223-1:2022

Custom-made medical devices

- Preparation of a technical documentation for keeping by a manufacturer or an authorized representative.

GXP is a reliable regulatory partner for success of your company on the market of medical devices.

We provide comprehensive services of:

Medical devices classification:

- Preparation of an application and a set of documents for submission to a Conformity Assessment Body to approve a medical device’s class.

Execution of technical documentation:

- Preparation of a document “Principal requirements”;
- Preparation of a harmonized standards list;
- Execution of technical documentation in Ukrainian according to requirements of a Technical regulation.

Professional assistance in the process of placing on the market class I medical devices:


- Preparation of a Declaration of conformity;
- Preparation of a Power of attorney and of an Authorized representative Agreement;
- Preparation of an application and a set of documents according to the MOH Order №122 as of 10.02.2017 on maintenance of Register of persons, responsible for placing on the market of medical devices, active implantable medical devices, in vitro diagnostic medical devices, forms of notifications, list of data, herein and access to them;
- Result of our work is entering your company to the register!!!

Project support from development of medical devices to placing them on the market:


- Individual approach;
- Involvement of experts according to peculiarities of devices;
- Project plan development including determination of check points;
- Risk analysis;
- Assistance in choosing of subcontracting organizations for realization of non-clinical investigations, clinical investigations concerning determination of an expiry date, processes’ validation, etc.
- Preparation of a technical documentation;
- Development of a labeling and instruction for use;
- Support in the process of product certification in a chosen Body or introduction into the Register of persons, responsible for placing on the market of class I medical devices.

Execution of a Declaration of conformity:

- Preparation of bilingual Declaration in English and Poland with two Annexes: a list of products and a list of harmonized standards.

DSTU EN ISO 13485:2018 (development of QMS, implementation, certification support):

- Pre-certification audit of the manufacturing site by a qualified expert;
- Preparation of a report, recommendations and a QMS implementation plan;
- Composition of a quality guideline, risk analysis etc.
- QMS implementation on the manufacturing site, maintenance of records, training of personnel, internal audit;
- Support of a QMS certification procedure in a chosen Certification body;
- Result of our work is a Certificate of conformity to requirements of DSTU EN ISO 13485:2018!!!

Consulting services concerning labeling of medical devices:

- Labeling project development following requirements of the Law of Ukraine On maintenance of Ukrainian language as governmental, DSTU EN ISO 15223-1:2018 Medical devices. Symbols to be used with medical device labels, labeling and information to be supplied. Part 1: General requirements, the Law of Ukraine On protection of consumers’ rights, requirements of relative Technical regulation and other legislative requirements that can apply individually.

Custom-made medical devices (application submission to the State Service of Ukraine on Medicines and Drugs Control support):

- Preparation of an application and a set of documents for custom-made medical devices according to the Annex 9 of TR No. 753 and its submission to the State Service of Ukraine on Medicines and Drugs Control;
- Preparation of a technical documentation for keeping by a manufacturer or an authorized representative.

Obtaining a permit from the State Service of Ukraine on Medicines and Drugs Control for realization of clinical investigations:

- Preparation of an application and a set of documents concerning medical devices intended for clinical investigations according to the Annex 9 of TR No. 753 for their submission to the State Service of Ukraine on Medicines and Drugs Control;
- Preparation of a technical documentation for keeping by a manufacturer or an authorized representative.

Conformity assessment support:


- Individual approach;
- Involvement of experts according to peculiarities of devices;
- Recommendations on choosing a conformity assessment procedure;
- Communication with a chosen Conformity Assessment Body;
- Preparation of technical documentation (technical file) according to requirements of Technical regulations;
- Preparation of Declaration of conformity;
- Recommendations concerning labeling and instructions for use;
- Result of our work is a conformity assessment certificate!!!

Authorized representative in EU and CIS for manufacturers non-residents

- Preparation and maintenance of technical documentation (technical file) according to the requirements of MDR (Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices) and IVDR (Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices):
Classification of medical devices
Risk analysis
Biological assessment
Clinical assessment
EC Declaration of Conformity
Labeling
Other documents
- Certification of I class medical devices.
- Conformity assessment support (cooperation with selected Notify Bodies)
- EN ISO 13485:2016 (development of QMS, implementation, certification support)

GXP by numbers

GXP’s mission – to facilitate the process of medical devices legalization and to create a legal way for new players to enter the EU and CIS market of medical devices, which in general will lead to qualitative changes in the market.

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CONTACTS

ul.Lubicz 27/40, 31-503

Krakow, Poland

 

+48 1225 44 831
+48 6906 25 630

 

info@gxp-europe.com

gxp-europe.com

Our competence

We are a team of experts with a broad experience in medical devices (MD) regulation (MD), good manufacturing practice (GMP), good distribution practice (GDP). We know irreproachably requirements of the national and European legislation.

We constantly learn and develop

We monitor changes in legislation

We cooperate with accredited laboratories and notified bodies.

We audit potential subcontracting service providers before we start our cooperation.

CONTACTS

ul.Lubicz 27/40, 31-503

Krakow, Poland

 

+48 1225 44 831
+48 6906 25 630

 

info@gxp-europe.com

gxp-europe.com

 

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