Company

CE Certiso Kft. is a Notified Body, our identification number is NB2409.

CE Certiso has been established in 2011 to perform quality management system certification and CE conformity assessment of medical devices.

CE Certiso is an accredited certification body: we perform quality management system audit and certification according to the EN ISO 13485:2016 standard in accordance with the requirements of ISO/IEC 17021-1:2015.  Our certification activity is performed by multilingual auditors with several years of experience.

CE Certiso is a Notified Body:  we perform surveillance of Directive (MDD, IVDD and AIMD) certificates in the transitional period provided by MDR and IVDR.

CE Certiso is and MDR-designated Notified Body: we perform conformity assessment of medical devices in accordance with the EU Regulation 2017/745 (MDR), our designation scope is available on the NANDO website.

During our conformity assessment activity, we also take into consideration the regulation of Team-NB’s Code of Conduct for Notified Bodies under Directives 90/385/EEC and 93/42/EEC.

CE Certiso Kft. does not have any subsidiaries.

CE Certiso aims to operate precisely and reliably.

In order to ensure good cooperation between our customers and our company, we pay special attention to impartiality and confidentiality.

The Declaration of Confidentiality, Independence and Impartiality of the management of CE Certiso Kft. is available in the Company menu.

Our liability insurance covers our activities in all countries of the world.

Our company is a member of Hungarian Standards Institution, we take part in the standardization activity.

1. ISO 13485

2. Surveillance of MDD, AIMD and IVD certificates

3. Conformity assessment according to MDR

The purpose of CE Certiso Kft. is to work on the field of medical devices and in vitro diagnostic medical devices as a professionally respected, financially successful certification body as one of the accredited and designated organizations.

The mission of our company is to contribute to the success of our clients in business by acting in a responsible, prepared, impartial and open way, treating the cases confidentially, and taking the safety requirements of the final users of the products that we certify as an absolute priority during the quality management system certification and the CE conformity assessment. Our purpose is to make our clients satisfied during the certification procedure. We respond to their potential complaints quickly and evaluate them impartially.

The company’s management and all employees are committed to the maintenance and continuous improvement of the management system of CE Certiso Kft., which are, among other things, accomplished by regular internal audits. Determination and evaluation of the quality policy and quality objectives is taken at management reviews.

During our activity, beside the regulations, standards, and common specifications of Hungary and the EU, we apply the certification-related documents of the competent organizations of the European Union, we continuously track their changes and also follow the technology improvements. For this purpose, we provide regular continuing training for our employees, who, otherwise, have the prescribed qualification, preparedness, and certification experience.

Management of CE Certiso Kft. hereby declares:

We treat confidentially all conformity assessment and certification-related information that has come to our attention during our official and unofficial activity and we respect the proprietary rights of intellectual property and material goods. Obligation of confidentiality of handling information is maintained for 3 years after the termination of our relationship with CE Certiso Kft. If unauthorized parties become aware of confidential information through us, we’ll take legal responsibility for it.

We declare that we are not the designer, manufacturer, supplier, installer, purchaser, owner or maintainer of devices which we assess, nor the authorised representative of any of those parties. Such restriction shall not preclude the purchase and use of assessed devices that are necessary for the operations of the notified body and the conduct of the conformity assessment, or the use of such devices for personal purpose.

We declare that we are not involved in the design, manufacture or construction, marketing, installation and use, or maintenance of the devices for which we are designated, nor represent the parties engaged in those activities.

We declare that we do not engage in any activity that may conflict with our independence of judgement or integrity in relation to conformity assessment activities for which we are designated.

We declare that we do not offer or provide any service which may jeopardise the confidence in our independence, impartiality or objectivity. In particular, we shall not offer or provide consultancy services to the manufacturer, its authorised representative, a supplier or a commercial competitor as regards the design, construction, marketing or maintenance of devices or processes under assessment.

We declare that we are not linked to any organisation which itself provides consultancy services as referred to above. Such restriction does not preclude general training activities that are not client-specific and that relate to regulation of devices or to related standards.

We declare that we do not carry out an external specific (only for a specific organization) training activity by designer, manufacturer, supplier, installer, purchaser, owner or maintainer of devices which we assess, nor the authorised representative, consultant of any of those parties.

We declare that we do not accept a high-value gift and/or service from the evaluated system operator and/or the device manufacturer, authorized representative, consultant, supplier.

In case we were formerly employed by a specific client, or provided consultancy services in the field of devices to that specific client prior to taking up employment with CE Certiso Kft., we shall not be assigned for conformity assessment activities for that specific client or companies belonging to the same group for a period of three years.

Management of CE Certiso Kft.

• Papp Valter dr.

• Kiss-Helmajer Kitti

• Czagányi Zoltán

• Horváth Ágnes dr.