General Data Protection Regulation- GDPR

General Data Protection Regulations

Everything you need to know about the General Data Protection Regulation- GDPR 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 […]

EN 1639:2009 Dentistry – Medical devices for dentistry

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

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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

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

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

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

IEC 60601-1-11:2015-Medical electrical equipment

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

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

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 […]

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