As DANEM MDC, our most important principle is to provide reliable service based on objective data by treating all companies/persons whose applications have been received equally and impartially under all circumstances, regardless of their geographical location, size, and the associations or organizations of which they are members, ensuring that our committees and employees adhere to the principles of confidentiality and impartiality throughout all stages of conformity assessment, without being subjected to pressure from any party and without considering the interests of any institution or person in the activities they carry out.

In order to ensure this, DANEM MDC has analyzed possible conflicts of interest through its risk management process and has taken the necessary measures. Continuous evaluation of the assurance of its impartiality is carried out through Impartiality Committee meetings held at least once a year.

In accordance with the requirements of accreditation standards and the relevant mandatory documents, it has ensured through its implemented procedures that the persons involved in the decision-making mechanism are different from those involved in the conformity assessment process. The top management of DANEM MDC undertakes that it will not have any positive or negative influence on the conformity assessment decision-making process, that it will terminate the conformity assessment process when it identifies any situation that may affect its impartiality, and that it will refrain from any behavior that may damage the reputation of the organizations to which it provides services.

DANEM MDC provides the necessary resources to carry out all conformity assessment activities with an authorized, transparent, impartial, independent, and unbiased attitude. We undertake that we have assumed and continue to assume full responsibility for all our mandatory duties related to the regulations to which we are designated, the standards to which we are accredited, the relevant annexes of these regulations and standards, and all fields in which we carry out conformity assessment activities.

DANEM MDC does not engage in any activity related to conformity assessment activities that would conflict with the independence of its decisions and evaluations. It is neither the designer, manufacturer, supplier, installer, commercial purchaser, owner, commercial user, or maintainer of the products whose conformity it assesses, nor the owner, authorized representative, or partner of these parties. Furthermore, it is not directly related to other products that are in competition with the products subject to conformity assessment (such as competing brands or manufacturers).

DANEM MDC undertakes that, in every field in which it is authorized and active, it fully assumes and fulfills the requirements of the relevant regulations, standards, and their annexes.

DANEM MDC does not audit or certify the quality management system of another certification body.

The top management of DANEM MDC guarantees that all information (technically and commercially) received from the applicant organization and identified within the organization during every stage of the conformity assessment processes it will carry out will be protected by it. All information, documents, papers, and records sent to us by the organization at all stages related to the services provided are accepted as confidential, and the necessary protection is provided by us.

The employees of DANEM MDC are also personally responsible for protecting this information and ensuring that it is kept confidential. DANEM MDC has guaranteed confidentiality through the confidentiality agreement signed by all its employees (internal and external). These confidentiality obligations continue even after the working periods of all employees have ended.

The remuneration of top management, personnel, and contractors is not dependent on the results of conformity assessment activities. DANEM MDC determines all its remuneration policies in line with the principles of impartiality, independence, and prevention of conflicts of interest.

Within the scope of product conformity assessment and quality management system assessment activities, DANEM MDC pays attention to the following matters in personnel assignments:

Assigned personnel; shall not take part in the design, manufacture, marketing, installation, use, or maintenance/technical service of the devices to which they are assigned and cannot be the representative of the persons carrying out these activities; they cannot be full-time or part-time, paid or unpaid employees.
They shall not offer or provide consultancy services, including one-to-one training, to the manufacturer, the manufacturer’s authorized representative, a supplier, or a commercial competitor regarding the design, manufacture, marketing, or maintenance/technical service of the devices or processes they evaluate; they cannot have ties with organizations providing consultancy services on these matters.
They shall not engage in any activity that may impair their honesty and independence regarding the conformity assessment activities to which they are assigned.
They shall not work as a researcher and/or principal investigator in a medical device company, its authorized representative, a supplier, or a commercial competitor (for example; conducting a clinical investigation).

They shall not obtain financial benefit from a medical device company, its authorized representative, a supplier, or a commercial competitor (such as owning stocks, shares, bonds/investment funds, pension funds, etc.; receiving compensation, fees, salary, grants, rent, scholarships, sponsorship; having conference/seminar participation expenses covered; owning patents, trademarks, technical information and/or copyrights related to medical devices personally benefited from).
They cannot receive training from the medical device company, its subcontractor, or its authorized representative.

In order to ensure that the past experiences of its personnel do not put at risk the impartiality, independence, and objectivity of the evaluation processes of the customers it serves, DANEM MDC does not assign conformity assessment personnel to the conformity assessment activities of its customers in the following situations:

For quality management system audits according to ISO 13485 standard, during the last 2 years; taking a role in the company and/or group companies to be evaluated (being a full-time/part-time, paid/unpaid employee of the company).
For EU 2017/745 MDR conformity assessment, working in the company and/or group companies to which they are assigned as the designer, manufacturer, supplier, installer, purchaser, owner, or maintenance/technical service provider of the device they evaluate. Working in the clinical investigation of that device.
For quality management system audits according to ISO 13485 standard during the last 2 years; for EU 2017/745 MDR conformity audits during the last 3 years, providing consultancy, company-specific training, internal audit service to the company and/or companies of the same group, or working in a consultancy firm that provides such services. (According to ((EU) 2017/745 Annex VII clauses 1.2.3(d), 1.2.4)); Receiving training services from the company and/or group companies, its authorized representative, or subcontractor.
DANEM MDC does not provide services to organizations with kinship relationships that endanger impartiality, in order to prevent kinship relationships from affecting the activities it carries out.
DANEM MDC does not subcontract audit and certification decision activities to organizations that provide consultancy services.

DANEM MDC determines the fees for the services it provides to all its customers in the fields in which it is authorized and operates according to the procedures it has established and does not apply different pricing (cheaper or more expensive) to any customer. It carries out the services it provides according to the procedures it has established in compliance with the relevant standards and regulations. It does not apply a simpler or faster process.

DANEM MDC undertakes not to engage in any commercial activity within the scope of the certification services it provides in the field of medical devices.

DANEM MDC and its personnel have adopted the principle of openness in communication with the relevant enterprise and other parties in all certification, testing, and verification activities, within the framework of confidentiality principles. DANEM MDC personnel, except for notified bodies, competent authorities for medical devices in member states, or personnel responsible for the commission, are obliged to comply with the rules of professional secrecy while performing their duties. Property rights shall be protected. The final responsibility regarding the exchange of information with the competent authority and the accreditation body lies with the top management.

DANEM MDC shall ensure that all activities and services it carries out are performed by competent personnel in such a way as to meet customer expectations and needs, in compliance with legal requirements and national and international standards.

DANEM MDC assumes the authority and responsibility for making decisions related to certification activities; these decisions include certification, refusal, continuation, renewal, extension and reduction of scope, suspension, lifting of suspension, and withdrawal. These decisions can never be delegated to external sources. It shall ensure that the Certification Committee of DANEM MDC takes certification-related decisions completely independently.

At DANEM MDC, access to certification processes is not dependent on the size of the customer, membership in any association or group, or the number of existing certifications.

Regarding pricing matters, DANEM MDC works under consistent, fair, and reasonable conditions, taking into account the interests of SMEs, as stated in the regulation on the definition, characteristics, and classification of small and medium-sized enterprises.

With the confidentiality agreement, all employees involved and not involved in the certification process undertake that they will carry out the relevant process operation in accordance with the requirements of the signed agreement and will apply the confidentiality requirements at all stages of this process.

Within the system we have established in accordance with national and international rules, principles such as independence, impartiality, and confidentiality, the analysis of situations that may cause conflicts of interest, and the provision of resources are clearly stated and declared in our documents.

DANEM MDC and all its employees keep confidential all written and verbal information received from companies and relevant parties regarding certification and inspection activities and share such information only with TÜRKAK and the Ministry of Health of the Republic of Türkiye, which accredit and authorize DANEM MDC, if requested by these institutions under the agreements signed and if not prohibited by law. Sharing with other third parties is made only by court order. When DANEM MDC has to provide information to third parties due to a court order, it always informs the relevant customer.

DANEM MDC has restricted access to confidential information to authorized persons. In addition, documents containing confidential information are stored in secured areas. The server/computer where the information is stored is also protected against external intrusions with special protection programs. In the event of termination of duty at any time, the relevant personnel immediately return all equipment, documents, and records related to the organization served during the term of duty without taking any copies or records, and return all copies and summaries of all such documents and all other notes, written records, photographs, drawings, and other materials made or provided by him/her or given to him/her. DANEM MDC guarantees the return of the documents (electronic and/or printed documents) provided by the conformity assessment personnel regarding the organization served through the service, confidentiality, and impartiality agreements it has concluded with the personnel.

All employees within DANEM MDC, whether personnel working in the certification and assessment process, or full-time or part-time auditors, technical experts, and clinical experts, perform their duties in complete independence. This independence is one of the basic principles of DANEM MDC and requires staying away from all commercial, financial, and other kinds of pressure. In addition, all board and committee members taking part in duties are also obliged to comply with the same principle of independence and freedom from pressure.

This principle of independence ensures that the services provided by DANEM MDC are carried out in an impartial and objective manner. Employees have the ability to make independent decisions in the duties assigned to them, and these decisions are made without any external influence. With this declaration, DANEM MDC guarantees that all its employees are and will remain independent from commercial, financial, and other pressures.

In line with these principles, DANEM MDC carries out all its activities and services in accordance with ethical rules and established standards. This principle, which is one of the core values of DANEM MDC, aims to protect and preserve the independence of each employee and board member. In the event of any conflict of interest, the situation is addressed and resolved quickly and effectively.

DANEM MDC undertakes to be impartial and fair in its activities and, in this context, protects the independence of all its employees and board members. In any situation that may create a conflict of interest, the situation is immediately examined and resolved by taking the necessary steps. This approach ensures that DANEM MDC provides its services at the highest ethical standards and in an impartial manner.

As top management, we undertake that all employees of DANEM MDC will operate in strict adherence to the principles of independence, impartiality, and confidentiality. This commitment applies to all employees at every level of DANEM MDC and includes remaining independent from all commercial, financial, and other pressures. In addition, in terms of the reliability and integrity of our services, the confidentiality of all information will be meticulously protected.

Our loyalty to these principles ensures that the services we provide to our customers are impartial and reliable. The competent and experienced staff of DANEM MDC provides services at the highest ethical standards by staying away from all kinds of conflicts of interest. In this context, as DANEM MDC, we undertake to continuously maintain the trust and satisfaction of our customers by adhering to these principles in all our activities.

As top management, we declare the following to the public from the notified body for which we are responsible:

We have no personal interest as a product developer, manufacturer, supplier, installer, purchaser, owner, or maintainer of the devices assessed, or as the authorized representative of any of these parties. Such restrictions shall not prevent the purchase and use of devices necessary for the activities of the notified body and the conduct of conformity assessment, or the use of such devices for personal purposes;

As top management, we are not engaged in the design, manufacture, construction, marketing, installation, use, or maintenance of the devices to which the services of DANEM MDC are assigned, and we do not represent the parties carrying out these activities;

As top management, we do not engage in any activity that may adversely affect our independent judgment or integrity in relation to conformity assessment activities; in particular, we declare that we do not engage in any professional activity that may create a potential conflict, that we do not directly or indirectly hold shares in commercial enterprises in the field of medical devices, that we do not take an active role in the management or supervisory boards of any company, and that we do not have close personal or family ties with organizations in this field;