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, […]
HACCP-Hazard Analysis and Critical Control Point
What is HACCP-Hazard Analysis and Critical Control Point? HACCP-Hazard Analysis and Critical Control Point is a systematic approach to food safety management. It is a preventative system that helps identify, evaluate, and control potential hazards in food production processes to ensure the safety of the final product. HACCP is widely used in the food industry […]
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 […]
ISO 15223-1:2021-Medical devices
What is ISO 15223-1:2021-Medical devices -Symbols to be used with information to be supplied by the manufacturer? ISO 15223-1:2021 provides guidelines and requirements for the use of symbols in medical device labelling and accompanying information provided by the manufacturer. Here are the key aspects covered by ISO 15223-1:2021: Scope and Purpose: The standard defines 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 14971:2019 – Medical Devices – Application of Risk Management to Medical Devices
What is ISO 14971:2019? ISO 14971:2019 is the international standard that outlines a comprehensive framework for the risk management of medical devices throughout their lifecycle. It provides manufacturers with a systematic approach to identifying hazards, estimating and evaluating risks, controlling those risks, and monitoring the effectiveness of those controls. This standard is essential for meeting regulatory requirements in global […]
ISO 10993 – Biological Evaluation of Medical Devices
ISO 10993 Part-1 to 23 – Biological Evaluation of Medical Devices ISO 10993-Biological evaluation of medical devices is a series of international standards that outline the biological evaluation of medical devices. These standards are published by the ISO and are used to assess the potential risks associated with the use of medical devices on living […]
ISO 13485:2016 – Medical Devices Quality Management Systems (MDQMS)
What is ISO 13485:2016? ISO 13485:2016 is the global standard for Medical Devices Quality Management Systems (MDQMS). It defines the requirements for organizations involved in the manufacturing, design, and distribution of medical devices to consistently meet customer and regulatory requirements. ISO 13485 is customized to the medical device industry, with a strong focus on risk […]
