ISO 13485 Australia Apply Online: Ensuring Quality Management for Medical Devices
Introduction The medical device industry plays a crucial role in ensuring the health and well-being of people around the world. With the constant advancements in technology, it is essential to have a robust quality management system in place to ensure the safety and effectiveness of medical devices. ISO 13485 is an internationally recognized standard that […]
ISO Certifications
Global Issues in 2023 and How ISO Certifications Can Help -Introduction The year 2023 has been marked by a multitude of global challenges that range from environmental degradation to cybersecurity threats, labor safety concerns, and quality management issues in various industries. These challenges not only affect individual organizations but also have far-reaching implications for societies […]
ISO CERTIFICATIONS IN MOROCCO
ISO Certifications in Morocco: Ensuring Quality and Compliance-Introduction: ISO Certifications in Morocco-In today’s globalized and competitive business environment, ensuring quality and compliance is of utmost importance for companies in Morocco. One effective way to achieve this is by obtaining ISO certifications. ISO (International Organization for Standardization) certifications provide a framework for companies to establish and […]
IEC 62304:2006-Medical device software
What is IEC 62304:2006-Medical device software — Software life cycle processes IEC 62304:2006-Medical device software, published by the International Electrotechnical Commission (IEC) that outlines the software life cycle processes for medical device software, it provides guidelines and requirements for the development and maintenance of software used in medical devices, ensuring that these software components are […]
IEC 60601-1-11:2015
What is IEC 60601-1-11:2015-Medical electrical equipment? IEC 60601-1-11:2015-Medical electrical equipment is a collateral standard in the IEC 60601 series of standards. The IEC 60601 series of standards specifies requirements for the safety and essential performance of medical electrical equipment and systems. Each part of the series focuses on different aspects of medical electrical equipment, and […]
ISO 18113-1:2022-In vitro diagnostic medical devices
What is ISO 18113-1:2022-In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions, and general requirements? ISO 18113-1:2022 specifies the terms, definitions, and general requirements for the labeling of in vitro diagnostic medical devices. Here are some key aspects covered in ISO 18113-1:2022: Scope: The standard applies to […]
ISO 23640:2011-In vitro diagnostic medical devices
What is ISO 23640:2011-In vitro diagnostic medical devices — Evaluation of stability of in vitro diagnostic reagents? ISO 23640:2011 provides guidelines for the evaluation of stability of in vitro diagnostic (IVD) reagents. In vitro diagnostic reagents are substances or preparations used in diagnostic examinations performed outside the living body, typically in a laboratory setting. The […]
EN 343:2019 – Protective clothing
What is EN 343:2019 – Protective clothing? EN 343:2019 is a European standard that specifies requirements and test methods for protective clothing against foul weather. It is part of a series of standards that cover various aspects of protective clothing in different environments. EN 343:2019 specifically focuses on protective clothing designed to protect wearers from […]
ISO 13485:2016
What is ISO 13485:2016-Medical devices — Quality management systems? ISO 13485:2016 is an international standard for Quality Management Systems (QMS) specific to the medical device industry. It provides a framework for organizations involved in the design, development, production, installation, and servicing of medical devices to establish and maintain an effective quality management system. ISO 13485 […]
