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CERTIFICATIONS

Safety & Quality
in MedTech

Medical Devices -
Quality Management

Secure & Privacy Compliance

Information Security
Management

Process Maturity
& Excellence

Software Life Cycle
Process Assessment

Quality & Process Management

Quality Management
Systems

CERTIFICATIONS

Safety & Quality
in MedTech

Medical Devices -
Quality Management

Secure & Privacy Compliance

Information Security
Management

Process Maturity
& Excellence

Software Life Cycle
Process Assessment

Quality & Process Management

Quality Management
Systems

CERTIFICATIONS

Safety & Quality
in MedTech

Medical Devices -
Quality Management

Secure & Privacy Compliance

Information Security
Management

Process Maturity
& Excellence

Software Life Cycle
Process Assessment

Quality & Process Management

Quality Management
Systems

CERTIFICATIONS

Safety & Quality
in MedTech

Medical Devices -
Quality Management

Secure & Privacy Compliance

Information Security
Management

Process Maturity
& Excellence

Software Life Cycle
Process Assessment

Quality & Process Management

Quality Management
Systems

QUALITY POLICY

Document Number: KP.01

Publication Date: 16.03.2025

As LUNARCHY TEKNOLOJİ AŞ, we are committed to supporting our quality management in the development and implementation of our quality system established in accordance with the EN ISO 13485:2016 standard. We undertake to ensure its compliance, adequacy, effectiveness, and continuous improvement through regular review and maintenance of its effectiveness.

The quality policy of LUNARCHY TEKNOLOJİ AŞ is structured around the following core principles, with the objective of ensuring that all employees share the responsibility for quality, that stakeholder expectations are met to ensure satisfaction, and that customers are provided with the most excellent products and after-sales services on time and at fair prices - ultimately aiming to exceed expectations:

Designing AI-supported clinical decision support systems for the early diagnosis of rare diseases, including software development processes, validation, lifecycle management, maintenance and updates, and the secure processing, storage, and management of personal and health data by these systems in compliance with national and international regulations, thereby contributing to patient well-being and quality of life through innovative approaches,
Providing usability advantages to physicians with a developer and designer vision,
Developing products in design processes that comply with and exceed national laws, standards, and international requirements,
Maintaining and continuously improving the effectiveness of our quality management system,

The quality policies of LUNARCHY TEKNOLOJİ AŞ serve as a framework for setting and reviewing quality objectives, guiding the strategic direction of the company and the allocation of its resources within the scope of these policies.

INTEGRATED MANAGEMENT SYSTEMS POLICY

Document Number: PLT.00/01

Publication Date: 02.01.2025

The main theme of TS EN ISO 27001:2022 Information Security Management System, TS EN ISO 27701 Personal Data Management System, and TS EN ISO 9001 Quality Management System (QMS) is to demonstrate that LUNARCHY TEKNOLOJİ AŞ ensures information security management within its human resources, infrastructure, software, hardware, customer information, organizational information, third-party information, and financial resources; to secure risk management; to measure the performance of information security management processes; and to regulate relationships with third parties regarding information security issues.

In this context, the purpose and objectives of our ISMS-QVMS-QMS Policies are:

To protect LUNARCHY TEKNOLOJİ AŞ against all kinds of threats that may occur from within or outside, knowingly or unknowingly; Protecting information assets, ensuring access to information as required by business processes, ensuring waste management, meeting legal and regulatory requirements, and conducting continuous improvement efforts.
Ensuring the continuity of the three fundamental elements of the Information Security Management System in all activities carried out:
- Confidentiality: Preventing unauthorized access to important information.
- Integrity: Demonstrating that the accuracy and integrity of the information are ensured.
- Accessibility: Demonstrating that authorized persons can access the information when necessary.
Within the scope of ISMS-QMS-QMS, uninterrupted management of Integrated Management Services,
Dealing with the security of all data, not only data kept in electronic form, but also data in written, printed, oral and similar formats.
Providing Information Security Management training to all personnel to raise awareness.
Reporting all vulnerabilities, whether real or suspected, in Information Security to the EMS team and ensuring their investigation.
Preparing, maintaining and testing business continuity plans.
Complying with current laws, regulations and decrees.
To identify existing risks by conducting periodic assessments on information security.
To review and monitor action plans based on the assessment results.
To prevent any disputes and conflicts of interest that may arise from contracts.
To meet business requirements for information accessibility and information systems.

Document Number: PLT.00/01

Publication Date: 02.01.2025

To protect LUNARCHY TEKNOLOJİ AŞ against all kinds of threats that may occur from within or outside, knowingly or unknowingly; Protecting information assets, ensuring access to information as required by business processes, ensuring waste management, meeting legal and regulatory requirements, and conducting continuous improvement efforts.
Ensuring the continuity of the three fundamental elements of the Information Security Management System in all activities carried out:
- Confidentiality: Preventing unauthorized access to important information.
- Integrity: Demonstrating that the accuracy and integrity of the information are ensured.
- Accessibility: Demonstrating that authorized persons can access the information when necessary.
Within the scope of ISMS-QMS-QMS, uninterrupted management of Integrated Management Services,
Dealing with the security of all data, not only data kept in electronic form, but also data in written, printed, oral and similar formats.
Providing Information Security Management training to all personnel to raise awareness.
Reporting all vulnerabilities, whether real or suspected, in Information Security to the EMS team and ensuring their investigation.
Preparing, maintaining and testing business continuity plans.
Complying with current laws, regulations and decrees.
To identify existing risks by conducting periodic assessments on information security.
To review and monitor action plans based on the assessment results.
To prevent any disputes and conflicts of interest that may arise from contracts.
To meet business requirements for information accessibility and information systems.

Document Number: PLT.00/01

Publication Date: 02.01.2025

To protect LUNARCHY TEKNOLOJİ AŞ against all kinds of threats that may occur from within or outside, knowingly or unknowingly; Protecting information assets, ensuring access to information as required by business processes, ensuring waste management, meeting legal and regulatory requirements, and conducting continuous improvement efforts.
Ensuring the continuity of the three fundamental elements of the Information Security Management System in all activities carried out:
- Confidentiality: Preventing unauthorized access to important information.
- Integrity: Demonstrating that the accuracy and integrity of the information are ensured.
- Accessibility: Demonstrating that authorized persons can access the information when necessary.
Within the scope of ISMS-QMS-QMS, uninterrupted management of Integrated Management Services,
Dealing with the security of all data, not only data kept in electronic form, but also data in written, printed, oral and similar formats.
Providing Information Security Management training to all personnel to raise awareness.
Reporting all vulnerabilities, whether real or suspected, in Information Security to the EMS team and ensuring their investigation.
Preparing, maintaining and testing business continuity plans.
Complying with current laws, regulations and decrees.
To identify existing risks by conducting periodic assessments on information security.
To review and monitor action plans based on the assessment results.
To prevent any disputes and conflicts of interest that may arise from contracts.
To meet business requirements for information accessibility and information systems.

Document Number: PLT.00/01

Publication Date: 02.01.2025

To protect LUNARCHY TEKNOLOJİ AŞ against all kinds of threats that may occur from within or outside, knowingly or unknowingly; Protecting information assets, ensuring access to information as required by business processes, ensuring waste management, meeting legal and regulatory requirements, and conducting continuous improvement efforts.
Ensuring the continuity of the three fundamental elements of the Information Security Management System in all activities carried out:
- Confidentiality: Preventing unauthorized access to important information.
- Integrity: Demonstrating that the accuracy and integrity of the information are ensured.
- Accessibility: Demonstrating that authorized persons can access the information when necessary.
Within the scope of ISMS-QMS-QMS, uninterrupted management of Integrated Management Services,
Dealing with the security of all data, not only data kept in electronic form, but also data in written, printed, oral and similar formats.
Providing Information Security Management training to all personnel to raise awareness.
Reporting all vulnerabilities, whether real or suspected, in Information Security to the EMS team and ensuring their investigation.
Preparing, maintaining and testing business continuity plans.
Complying with current laws, regulations and decrees.
To identify existing risks by conducting periodic assessments on information security.
To review and monitor action plans based on the assessment results.
To prevent any disputes and conflicts of interest that may arise from contracts.
To meet business requirements for information accessibility and information systems.

Safety & Quality in MedTech

Secure & Privacy Compliance

Process Maturity & Excellence

Quality & Process Management

Safety & Quality in MedTech

Secure & Privacy Compliance

Process Maturity & Excellence

Quality & Process Management

Safety & Quality in MedTech

Secure & Privacy Compliance

Process Maturity & Excellence

Quality & Process Management

Safety & Quality in MedTech

Secure & Privacy Compliance

Process Maturity & Excellence

Quality & Process Management

Safety & Quality
in MedTech

Process Maturity
& Excellence

Safety & Quality
in MedTech

Process Maturity
& Excellence

Safety & Quality
in MedTech

Process Maturity
& Excellence

Safety & Quality
in MedTech

Process Maturity
& Excellence