icon

Check out our offer

icon

CeCert is a dynamically developing certification body offering its services in the area of ​​certification: management systems, IVD medical devices, and other services (including kindergartens and nurseries for compliance with anti-epidemic requirements) ), training, supplier audits. In 2019, we were entered on the list of authorized ERCA partners in the field of audit training, while from 2020 we have been accredited by the Polish Center for Accreditation for the QMS PN-EN ISO 9001: 2015-10 and MDMS PN-EN ISO 13485: 2016-04 programs ( scope ). In October 2021, the Minister of Health authorized CeCert in the field of in-vitro diagnostic medical devices and appointed it as a notified body. On January 3, 2022, we were assigned the notified body number - 2934

We are PCA accredited according to the scope:   We are a recognized organization by:     Our scope
in the NANDO
      

person

We are a team of experts and professionals.

About
The CeCert team consists of experts and professionals in many fields, and above all enthusiasts with over 20 years of experience in working in domestic and foreign certification bodies. Our advantage is speed and flexibility. Cooperation with CeCert brings real added value.

CeCert is a harmonious team...

With many years of experience...

With amazing ideas...

And a focus on development

ico

Would you like to know us better?

ico

Call us

+48 721 721 527
ico

Or write to us

office@cecert.pl
hands

CeCert = the highest competences

Above all, competences

quote

Our high competences are confirmed by the results of the assesment of the Polish Center for Accreditation, the Ministry of Health and the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products. In the field of in-vitro diagnostic medical devices, we have a notification with the number 2934.

Kamil Szczurowski
Head of the IVD Medical Device Certification Department

CeCert is a good choice!

We are there for our clients!

quote

Our advantage is the individual approach to the client. We take every inquiry seriously and do not remain unanswered. We know that reaction time is key to running a business, so we encourage you to contact us so that you can see for yourself how quickly and efficiently we operate!

Alicja Dąbrowska
Head of the Management Systems Certification Department

CeCert - Your Certification Body

CeCert is created by people with passion

quote

CeCert Team consists of people who have proven competences and experience in their fields. Working in the certification body is our passion. Therefore, by choosing to cooperate with CeCert, you receive more than just management system or product certificates, you can be sure that the contracted process will be carried out at the highest level. Feel free to contact us!

Phd Michał Pachowski
CEO

CeCert means efficiency and speed!

Complex offer

quote

The key to the development of our offer is to ensure the comprehensiveness of the services provided. Therefore, in the field of medical devices, we have both the certification of management systems for compliance with ISO 13485, the certification of medical devices and a training package with an internal auditor and risk analysis, including.

Magdalena Maj-Nowisz
Head of Sales and Marketing

CeCert means perfect work organization and efficiency!

We look to the future

quote

To meet the expectations of our customers, in the near future we plan to submit an application for notification to Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, as well as Regulation of the European Parliament and of the Council (EU) 2017/746 of 5 April 2017 on in vitro diagnostic medical devices.

Konrad Łuźniak
Head of the Medical Device Certification Department

Best of the best

Our team evaluating technical documentation are the best experts in Poland!

quote

The team assessing the technical documentation of IVD medical devices are the best experts in this field in Poland, who have many years of experience in working in notified bodies, and previously with manufacturers of medical devices. Thanks to this, we perfectly navigate legal and normative provisions.

Piotr Macikowski
Manager of the IVD Medical Device Certification Department