Technical file Preparation According to EU MDR for class one Medical Product
Preparing a technical file for a Class I medical device according to the European Union’s Medical Device Regulation (EU MDR) is a critical step in compliance for market access within the EU, thus The technical file, or technical documentation, provides evidence that your medical device meets the necessary regulatory requirements. Here’s a detailed guide on […]
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 […]
PCI DSS Certification?
What is PCI DSS Certification? PCI DSS stands for Payment Card Industry Data Security Standard. It is a set of security standards designed to ensure that all companies that accept, process, store, or transmit credit card information maintain a secure environment. The PCI DSS is a global standard and is intended to protect cardholder data […]
ISO 9712:2021 Non-Destructive Testing
What is ISO 9712:2021 Non-Destructive Testing – Qualification and Certification of NDT Personnel? ISO 9712:2021 Non-Destructive Testing pertains to the qualification and certification of personnel involved in non-destructive testing (NDT). Non-destructive testing is a suite of techniques used to evaluate the integrity of materials, components, or systems without causing damage to them. The standard outlines […]
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, […]
EN 331:2015 Manually operated ball valves
What is EN 331:2015 Manually operated ball valves and closed bottom taper plug valves for gas installations for buildings? EN 331:2015 Manually operated ball valves is a European Standard that specifies the requirements and testing methods for manually operated ball valves and closed bottom taper plug valves. These valves are intended for use in gas […]
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 3082:2017 Iron ores
What is ISO 3082:2017 Iron ores — Sampling and sample preparation procedures? ISO 3082:2017 Iron ores standard is designed to establish rigorous methodologies for the sampling and preparation of iron ore samples across the supply chain, from the point of origin to the point of consumption. The objective is to ensure that the samples are […]
EN 10219-2:2019-Cold formed welded steel structural hollow sections
What is EN 10219-2:2019-Cold formed welded steel structural hollow sections -Tolerances, dimensions and sectional properties? EN 10219-2:2019 specifies the technical delivery conditions for cold formed welded structural hollow sections of non-alloy and fine grain steels. Part 2 of this standard focuses specifically on tolerances, dimensions, and sectional properties of these steel structural hollow sections. The […]
EN 403-Respiratory protective devices
What is EN 403-Respiratory protective devices for self-rescue. Filtering devices with hood for escape from fire-Requirements, testing, marking? EN 403 specifies the requirements, testing methods, and marking for respiratory protective devices with hood for self-rescue during escape from a fire. These devices are designed to provide respiratory protection to individuals who need to escape from […]
