KARADENIZ TECHNICAL UNIVERSITY MEDICAL DEVICE DESIGN AND PRODUCTION
APPLICATION AND RESEARCH CENTER REGULATION
FIRST PART
Purpose, Scope, Basis and Definitions
Purpose
ARTICLE 1 – (1) The purpose of this Regulation; It is to regulate the procedures and principles regarding the aims, fields of activity, management bodies, duties of the management bodies and the way of working of the Medical Device Design and Production Application and Research Center of Karadeniz Technical University.
Scope
ARTICLE 2 – (1) This Regulation; It covers the provisions regarding the aims, fields of activity, management bodies, duties and working methods of the Medical Device Design and Production Application and Research Center of Karadeniz Technical University.
Basis
ARTICLE 3 – (1) This Regulation; It has been prepared based on the sub-clause (2) of the first paragraph of Article 7 and Article 14 of the Higher Education Law No. 2547 dated 4/11/1981.
Definitions
ARTICLE 4 – (1) In this Regulation:
a) Advisory Board: Advisory Board of the Center,
b) Center (METAM): Karadeniz Technical University Medical Device Design and Production Application and Research Center,
c) Director: The Director of the Center,
ç) Rector: Rector of Karadeniz Technical University,
d) University: Karadeniz Technical University,
e) Board of Directors: The Board of Directors of the Center,
means.
SECOND PART
Aims and Fields of Activity of the Center
The aims of the center
ARTICLE 5 – (1) The aims of the Center are as follows:
a) Considering Turkey's goals of providing domestic production of medical devices and equipment, revising existing ones in terms of design and physiological compatibility, using advanced and innovative materials and production technologies, primarily aiming to increase the export-oriented competitiveness of Turkish industry in these areas. To do research in line with the problem, to solve problems that arise or may arise, or to contribute to their solution, and to try to ensure the implementation of these solution methods.
b) To support qualified workforce by developing sector-specific devices and tools/equipment in the medical device industry.
c) To contribute to Turkey's development goals by ensuring that the design, production and necessary tests of medical devices, intermediates and end products are carried out in accordance with national and international conditions.
Areas of activity of the center
ARTICLE 6 – (1) The activities of the Center are as follows:
a) New materials, products, processes, methods, technological systems and three-dimensional design and production by determining the priorities of private and public institutions and other relevant institutions and organizations serving in the medical device and equipment / equipment sector in accordance with the requirements of the country, in terms of research needs do research on systems; to carry out studies to develop products and systems used in medicine and to support ongoing studies within the means.
b) To participate in, prepare, present, support and follow up training activities for the qualified workforce needed by the medical and medical device industry.
c) Announcing the results of the research to the industrialists, determining the equipment, systems and features that are necessary for a new material, product, process or method to enter the production phase.
ç) To provide consultancy on equipment production and methods used in the medical device sector and technological difficulties encountered in enterprises; To help eliminate the causes of defects in processes, materials and products, to determine and control the properties of materials and products, to assist in programming and information processing studies and to make systematic device and equipment analysis.
d) To produce non-standard tools, equipment, devices and equipment that are difficult to produce in other research and education institutions and industrial establishments working in the medical device production sector, and to develop special tools and equipment for country researchers within the Center, and those who are needed, both themselves, to produce for both other research and industrial establishments, and to perform adjustment, analysis, testing and similar services for special and sensitive tools and equipment, within the bounds of possibility.
e) To produce a limited number of prototypes in order to examine a production technique and the problems in this technique when necessary.
f) Organizing or participating in scientific meetings such as seminars, symposiums, congresses, conferences, workshops, making publications, organizing or participating in research and development fairs on the subjects that fall within the scope of the Center's work areas.
g) To carry out contracted medium-term research and development projects supported by industry and public institutions in line with the objectives of the Center defined in Article 5, in line with the demands of these institutions; long-term, special-purpose applied strategic research.
ğ) To establish businesses and/or become partners in line with the relevant legislation in order to put research and development results into practice.
h) To train the researcher and technical personnel of the centre, to assist in the training of the researcher and technical personnel working in universities, industrial sector and other research institutions.
ı) To provide technical consultancy, analysis, inspection, measurement and inspection services to relevant industrial organizations and individuals.
THIRD PART
Governing Bodies and Duties of the Center
The governing bodies of the center
ARTICLE 7 – (1) The governing bodies of the Center are as follows:
a) Director.
b) Board of Directors.
c) Advisory Board.
Director
ARTICLE 8 – (1) Director; He is appointed by the Rector for three years from among the lecturers working in the relevant departments of the University and experienced in the relevant fields. The Director whose term of office has expired may be reassigned.
(2) by the Rector; Upon the recommendation of the Director, the Rector may assign two assistant principals to assist the Director in his work, from among the teaching staff at the University. The duties of the Deputy Directors end when the term of the Director ends.
(3) In cases where the manager cannot be on duty, he appoints a deputy manager or one of the members of the Board of Directors. If the Manager is absent for more than six months, his duty ends and a new Manager is appointed.
Manager's duties
ARTICLE 9 – (1) The duties of the director are as follows:
a) To ensure that the activities of the Center are carried out regularly and efficiently in line with the general strategies determined by the Board of Directors.
b) To take and implement all kinds of decisions appropriate to the purpose and activities of the Center.
c) With the approval of the Rector, to carry out and ensure the execution of the works and procedures related to the creation, execution, realization and conclusion of the Center's research and project planning and budgets.
ç) To ensure coordination among the central bodies.
d) To determine the personnel needed in the center and submit it to the approval of the Rector.
e) To prepare the annual budget, to implement the accepted annual budget, to prepare the income-expenditure balance accounts at the end of the year and present them to the Board of Directors.
f) To preside over the Management and Advisory Boards.
Board of Directors
ARTICLE 10 – (1) Board of Directors; It consists of a total of six people, with at least one expert on medical devices and the Director. Provided that at most three of the members of the Board of Directors are in the University staff, they can also be selected from industrialists who have worked/worked in the medical device sector. Members are appointed by the Rector for a period of three years. The member whose membership period has expired can be reassigned. In case the membership becomes vacant for any reason, a new member is appointed by the Rector to complete the remaining term.
(2) Board of Directors; It may convene at least once a year ordinarily and when necessary, extraordinarily upon the invitation of the Director. The Board of Directors convenes with the absolute majority of the total number of members and the decisions are taken by the majority of the votes of the attendees. Votes are cast in the form of acceptance or rejection. In case of equality of votes, the majority of votes cast by the Director is deemed to have been achieved.
Duties of the Board of Directors
ARTICLE 11 – (1) The duties of the Board of Directors are as follows:
a) To determine the general strategies regarding the activities of the Center, to take and implement the decisions related to the purpose and field of work.
b) To elect the members of the Advisory Board and submit them to the approval of the Rector, to make proposals for their replacement when necessary.
c) To discuss and decide on the issues raised by the Manager on the issues determined in this Regulation.
Advisory Board
ARTICLE 12 – (1) Advisory Board; It consists of five people who are active in the working areas of the center, who are experts in the medical and manufacturing sector in the national and international arena, and who have theoretical and practical knowledge. Members of the Advisory Board are appointed by the Rector for a period of three years upon the recommendation of the Board of Directors. The member whose membership period has expired can be reassigned. If the membership becomes vacant for any reason, a new member is elected with the same procedure to complete the remaining term.
(2) The Advisory Board meets at least once a year under the chairmanship of the Director and takes all its decisions by majority vote of the members attending the meeting.
Duties of the Advisory Board
ARTICLE 13 – (1) The duties of the Advisory Board are as follows:
a) To advise the Board of Directors and the Director in the execution and development of the activities of the Center.
b) To make suggestions regarding the training activities of the Center.
c) To inform about technological developments in the sector.
ç) To assist in the procurement process of machinery and equipment.
CHAPTER FOUR
Miscellaneous and Final Provisions
Project teams and project managers
ARTICLE 14 – (1) A project team consisting of at least two people is formed by the Director to carry out the research, development and prototype production projects carried out by the Center. One of the people in the project team is assigned as the project coordinator by the Manager.
(2) Procedures and principles such as the formation of the project teams, their assignment, how many projects each researcher can take part in at the same time, preparation and acceptance of the project budgets are determined by the Senate with the proposal of the Director.
Training activities and their realization
ARTICLE 15 – (1) A training team consisting of at least two people is formed by the Center for the preparation of training plans, documents, machinery/equipment and training environments on the subjects determined by the Advisory Board. One of the people in the training team is assigned by the Director as the training coordinator.
(2) Procedures and principles such as the formation and assignment of education personnel, how many projects each researcher can take part in at the same time, preparation and acceptance of project budgets are determined by the Senate with the proposal of the Director.
Personnel needs
ARTICLE 16 – (1) The academic, technical and administrative staff needs of the Center; In accordance with Article 13 of the Law No. 2547, it is paid by the personnel assigned by the Rector.
Equipment and fixtures
ARTICLE 17 – (1) All kinds of tools, equipment and fixtures purchased within the scope of research supported by the Center are recorded in the inventory of the Center and allocated for their use.
Cases where there is no provision
ARTICLE 18 – (1) In cases where there is no provision in this Regulation, the provisions of other relevant legislation shall apply.
Force
ARTICLE 19 – (1) This Regulation shall enter into force on the date of its publication.
Executive
ARTICLE 20 – (1) This regulation is executed by the Rector of Karadeniz Technical University.
https://www.resmigazete.gov.tr/eskiler/2021/03/20210329-6.htm
