Unihelp is a consulting company in quality management systems.
With an experienced and high-qualified staff, mainly with focus on quality, Unihelp provides assurance in the ability to satisfy quality requirements and regulatory affairs. The needs of your company are handled with responsibility, immediacy, knowledge and experience and we are highly competent in developing and designing the required quality systems.
The Unihelp specialized staff has extensive experience in the development and implementation of quality management systems according to the standards:
We are specialized in the adaptation of companies that manufacture or distribute medical devices, in accordance with the newly-specified requirements of the European Union Medical Device Regulation (MDR) EU 2017/745, which concerns medical devices and has been in force since May 2021 as well as the corresponding regulation for in vitro diagnostic products IVDR 2017/746, which has been in force since May 2022.
We undertake and document the preparation of technical files for medical devices and the process of obtaining CE marking.
The Quality Policy of the company UNIHELP Ε.Ε. is guided by its overall strategy that aims to provide the best possible support to partner companies with high value-added services that are offered flexibly by its experienced executives.
The key components of the Policy are:
The company provides specialized and innovative Services in the field of Business Consultants. The goal of the company is to provide competitive and innovative services, with emphasis on the quality of these services and continuous customer satisfaction.
In order to achieve the above objectives, UNIHELP implement a Quality Management System in compliance with the requirements of the ISO 9001:2015 Standard.
The Quality Management System was designed and implemented based on the following principles:
UNIHELP EE is committed to complying with the requirements governing its services as well as to continuously improving the efficiency of the Quality Management System.
The Quality Management System is systematically evaluated, in order to achieve its continuous improvement and its efficiency.
The Quality Policy is available on request.
The content of the Quality Policy is reviewed annually in terms of its suitability.
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Provision of consulting services to businesses and organizations in accordance with the increased requirements of EU regulations.
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