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19th Ave New York, NY 95822, USA

Company

Our mission at TwoBull MediTherapy, is:

  • To offer In-Vitro Diagnostic Medical Devices through comprehensive and competitive Design, Development and Production declared and evidence based Roadmap, with the highest degree of Accuracy, Efficiency and Safety to every single potential end-user, regardless of their individual financial status, geographical location, and Academic or Training Background.

 

  • To develop, manufacture and market solely safe and effective In Vitro Diagnostic products to applicable specifications and intended uses, that meet fully National and International Standards as well as Applied relevant Regulatory Requirements.
  • To provide validated Innovative Diagnostic Solutions for the Accurate and Early Diagnosis of Aortic Aneurysms, in a personalised manner for General Population as well as of High-Risk Groups, thus Preventing abrupt eruption of undiagnosed Aneurysms, enhancing the relevant Therapeutic Methodologies by early Intervention, prolonging their individual survival and improving significantly their quality of life

 

  • To meet customers safety and satisfaction criteria and expectations without contradicting to applied and claimed National and International Standards as well as Regulatory Requirements

 

  • To continuously improve and optimize Company’s Quality Management System.
The above mentioned targets are accomplished through TwoBull Medi Therapy’s comprehensive and continuously updated QMS, by providing and promoting repeated training sessions for all employees along with active subcontractor’s interaction, participation and involvement, in order to ensure continuous optimisation and improvement of Company’s highly respected QMS processes.
TwoBullMediTherapy’s Top Management Team, is fully committed, whereas it undertakes the full responsibility in all aspects of this Quality Policy’s proper implementation and is solely responsible for the quality of its product, utilizing personal commitment of all its employees and represented by the Quality Management Representative, officially appointed and declared person.
TwoBull MediTherapy ensures to constantly provide the required and appropriate human and financial resources, as well as the necessary equipment to carry out the design, production, technical support, the distribution of the product(s) and finally to achieve its objectives, in a fully comprehensive manner.
TwoBullMediTherapy has developed Quality Management System, along with the associated procedures and work instructions to be complied as per EN ISO 13485:2016, as well as the European Regulation IVDR 2017/746 for in-Vitro Diagnostics Medical Devices, Annex IX, Chapter 1. Regulatory requirements always take absolute priority over customer or other business or individual Requirements.
TwoBullMediTherapy has developed and continuously implements a competitive and updated Quality Management System to demonstrate its capability to provide product (s) that meets the safety, stricter customer and regulatory requirements, consistently.
Additionally, Company’s QMS fulfils all the declared customer satisfaction targets and aims, through the effective implementation and holistic application of the system, including continual improvement and prevention of nonconformity.
TwoBullMediTherapy does not intend to introduce, release, marketing and sell any of its product(s) within the European Market, before the final official clearance and relevant certification approval of its products either by the National Competent Authority or before issuing CE mark by the designated Notified Body (-ies), respectively.
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