Compliance

Compliance Policy

Purpose

The purpose of this Compliance Policy is to establish and maintain the highest standards of legal, regulatory, and ethical conduct within PengyouX. Our goal is to ensure that our operations and services adhere to all applicable laws, regulations, and industry standards, thereby fostering trust, integrity, and transparency in all our business dealings.

Scope

This policy applies to all employees, contractors, and affiliates of PengyouX, as well as to all business activities conducted by the company. It encompasses compliance with regulatory requirements, industry standards, and ethical practices relevant to our operations, particularly in the medical device industry and international markets.

Regulatory Compliance

Adherence to Laws and Regulations

• We are committed to complying with all local, regional, and international laws and regulations applicable to our business. This includes, but is not limited to, medical device regulations in the Gulf Cooperation Council (GCC) region, as well as global standards such as ISO 13485, FDA QSR 21 CFR parts 820, 210/211, and 4, MDR, and MEDDEV guidelines.
• Regulatory Approvals
• We ensure that all medical devices and products managed by PengyouX meet the necessary regulatory approvals before entering the market. This involves thorough review and compliance with regulatory requirements for product registration, Clinical Evaluation Reports (CERs), and Quality Management Systems (QMS).

Ethical Conduct

• Integrity and Transparency
• We uphold the highest standards of integrity and transparency in all our business practices. This includes honest communication, ethical decision-making, and adherence to professional standards. We do not tolerate any form of corruption, bribery, or unethical behavior.
• Conflict of Interest
•  Employees and affiliates must avoid situations where personal interests could conflict with their responsibilities to PengyouX. Any potential conflicts of interest must be disclosed to management and addressed promptly.

Quality Management

• Compliance with Quality Standards
• We are dedicated to maintaining quality management systems that meet the applicable standards and regulations. This includes the development, implementation, and continuous improvement of processes that ensure the safety, efficacy, and quality of the products and services we support.
• Risk Management
• We implement robust risk management practices to identify, assess, and mitigate risks associated with our business operations and client projects. This includes maintaining up-to-date risk management files in accordance with ISO 14971:2019 and other relevant standards.

Training and Awareness

• Employee Training
• We provide regular training to all employees on compliance-related topics, including regulatory requirements, ethical standards, and quality management. Training programs are designed to ensure that employees are well-informed and equipped to adhere to our compliance policies.
• Ongoing Education
• We encourage ongoing education and professional development to stay current with changes in regulations, standards, and best practices. Employees are expected to engage in continuous learning to support compliance efforts.

Monitoring and Enforcement

• Compliance Monitoring
• We conduct regular audits and reviews to monitor compliance with this policy and relevant regulations. Any non-compliance issues identified are addressed promptly and effectively.

• Reporting and Investigation
  • Employees are encouraged to report any concerns or violations related to compliance through established reporting channels. We ensure that all reports are investigated thoroughly and confidentially, with appropriate corrective actions taken as necessary.

Commitment

PengyouX is dedicated to fostering a culture of compliance and integrity. Our commitment to this policy is unwavering, and we continuously strive to enhance our compliance practices to meet the highest standards. By adhering to this Compliance Policy, we ensure that our operations are conducted ethically, transparently, and in full compliance with all applicable laws and regulations.

Policy Review

This Compliance Policy will be reviewed periodically and updated as necessary to reflect changes in regulations, industry standards, and company practices. All updates will be communicated to employees and relevant stakeholders.