General Data Protection Regulation- GDPR
What is GDPR – General Data Protection Regulation? General Data Protection Regulation- GDPR represents a significant overhaul of data protection laws in the European Union (EU). It was implemented on May 25, 2018, to harmonize data privacy laws across Europe and to protect EU citizens’ data privacy. It not only applies to organizations located within […]
EN 1639:2009 Dentistry – Medical devices for dentistry
What is EN 1639:2009 Dentistry – Medical devices for dentistry – Instruments? EN 1639:2009 Dentistry – Medical devices for dentistry is a European standard that specifies the requirements and test methods for instruments used in dentistry, including but not limited to, hand-held cutting, drilling, and condensation instruments. This standard is designed to ensure the safety, […]
ISO 13485 Australia Apply Online: Ensuring Quality Management for Medical Devices
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 provides […]
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 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 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 Medical Devices – Quality Management Systems Certification
What is ISO 13485:2016 Medical Devices – Quality Management Systems? ISO 13485:2016 outlines the requirements for a comprehensive quality management system (QMS) specific to the medical devices industry. This standard is designed to be used by organizations involved in the design, production, installation, and servicing of medical devices and related services. ISO 13485 ensures that […]
