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July 26, 2022
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PROFILE
& QUALITY POLICY
Company Profile
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:
- ISO 9001: 2015 (Quality Management System)
- ISO 13485: 2016 (Quality System for Medical Devices)
- Ministerial Decision 1348 (Principles and Guidelines for Good Practice of Distribution of Medical Devices)
- EN 15224 (Quality System in Healthcare Organizations).
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.
WHAT IS INCLUDED
QUALITY POLICY
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:
- High quality services
- Pursuing the satisfaction of the expectations and needs of the collaborating companies with valid solutions
- The creation and development of long-term relationships with partner companies and vigilance to identify opportunities (development, business, technology) that can improve their operation or develop new directions and activities
- The pursuit of the optimal combination of high quality and economy in the solutions offered to the cooperating companies
- Continuous information and assimilation of new knowledge and innovations by the company’s executives
- The work of executives empowered with a strong sense of team spirit and a responsibility
- The provision of complete solutions
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:
- To be the basic mechanism for its optimal organization and operation
- To improve the quality of provided services.
- To ensure and improve the satisfaction of its customers, by providing services that meet their requirements.
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.
CONTACT
Tel.: +30 210 6233995
Fax: +30 210 62 33 997
Mob.: +30 6944 147 345
E-mail: info@unihelp.gr
Address:
12, Konstantinoupoleos str.
151 21 Pefki
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