21.06.2023
New CeCert AC 232 accreditation
We are very pleased to announce that on April 25 this year CeCert has been accredited by the Polish Center for...
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CeCert is a notified body
CeCert NB 2934
We are proud to announce that today, after two months of waiting, we have received the number in the NANDO database - 2934 - we invite you to cooperate
NANDO Base
PCA Accredited Program
ISO 13485 certification
Do you have the ISO 13485 system implemented? Or maybe you already have ISO 13485 certificate? Ask us for an offer! We know a lot about medical devices. Trust a PCA-accredited and authorized by the Ministry of Health certification body.
Ask for an offer today!
Sanitary Safety Certificate for Hotels
Sanitary Safety Certificate
The sanitary safety certificate for hotels is a confirmation by a third party that your facility provides services in accordance with the guidelines of the Minister of Development of GIS
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Assessment of documentation for compliance with the Act on medical devices
Class I medical devices
If you are an importer or distributor of medical devices and you are not sure if the product you sell meets the requirements, use CeCert services!
Class I medical devices
ISO 9001 Lead Auditor (ERCA) - stationary training
Lead Auditor ISO 9001
We invite you to the new edition of the Training Lead Auditor of the Quality Management System according to PN-EN ISO 9001: 2015 DO NOT WAIT! call 721 721 526!
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We are an ERCA Accredited Partner!
ERCA partner!
for the implementation of training for leading auditors according to ISO 27001 and ISO 9001. Details in the "Training" tab
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Check out our offer
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 | ||
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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
CeCert = the highest competences
Above all, competences
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!
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
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
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
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!
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
