Monthly Archives: April 2025

ISO 14155:2020 is the international standard that provides guidelines for the design, conduct, recording, and reporting of clinical investigations of medical devices involving human subjects. It aims to ensure the ethical and scientific quality of clinical trials, thereby safeguarding the … Continue reading →

In the evolving landscape of global healthcare, TEMOS International stands out as a pivotal force in elevating standards for medical tourism. Established in 2010, TEMOS provides comprehensive accreditation programs tailored to healthcare providers and medical travel coordinators, ensuring excellence in … Continue reading →

The World Medical Association (WMA) underscores the ethical and professional imperative of Continuous Quality Improvement (CQI) in healthcare. Through its “Declaration on Guidelines for Continuous Quality Improvement in Health Care,” adopted in 1997 and amended in 2009, the WMA provides … Continue reading →

The Declaration of Helsinki, established by the World Medical Association (WMA) in 1964, serves as a cornerstone document outlining ethical principles for medical research involving human participants. It has undergone multiple revisions, with the latest in 2024, to address evolving … Continue reading →

ISO 13485 is the internationally recognized standard that outlines the requirements for a Quality Management System (QMS) specific to the medical device industry. It provides a framework for organizations to ensure the consistent design, development, production, installation, and delivery of … Continue reading →

The IEC 60601 series, established by the International Electrotechnical Commission (IEC), sets the benchmark for the safety and essential performance of medical electrical equipment. Compliance with these standards is crucial for manufacturers aiming to ensure patient safety and meet regulatory … Continue reading →

ISO 14971 is the internationally recognized standard that provides a comprehensive framework for risk management in the medical device industry. It guides manufacturers in identifying, evaluating, controlling, and monitoring risks associated with medical devices throughout their entire lifecycle, from design … Continue reading →

In October 2023, the International Organization for Standardization (ISO) introduced ISO 7101:2023, marking a significant advancement in healthcare quality management. This standard offers a comprehensive framework tailored for healthcare organizations, aiming to enhance patient care, operational efficiency, and workforce well-being. … Continue reading →