Technical file preparation according to EU MDR for class one medical product

technical file

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 […]

PCI DSS Certification?

pci dss

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

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

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

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

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 7200:2004 Technical product documentation

What is ISO 7200:2004 Technical product documentation-Data fields in title blocks and document headers? ISO 7200:2004 Technical product documentation specifies the data fields used in the title blocks and headers of technical product documents. These documents can include engineering drawings, schematics, and other types of technical documents that are essential for product manufacturing, assembly, and […]

ISO 500-1:2014 (EN)

Agricultural Tractors — Rear-mounted power take-off types 1, 2, 3, and 4 Part 1: General specifications, safety requirements, dimensions for master shield and clearance zone.ISO 500-1:2014 (EN) was created by ISO/TC 23, Tractors and machinery for agriculture and forestry, Subcommittee SC 4, Tractors was created by ISO/TC 23, Tractors and machinery for agriculture. And forestry, […]

ISO 4157-1:1998(EN)

Construction drawings — Designation systems — Part 1: Buildings and parts of buildings ISO 4157 was created by Technical Committee ISO/TC 10, Technical drawings, product definition and related documentation, Subcommittee SC 8, and Construction documentation. ISO 4157 consists of the following parts, under the general title Construction drawings — Designation systems: Part 1: ISO 4157-1:1998(EN) […]

ISO 3601-1:2012 Fluid Power Systems

What is ISO 3601-1:2012 Fluid Power Systems -O-Rings-Inside Diameters, Cross-Sections, Tolerances and Designation Codes? ISO 3601-1:2012 Fluid Power Systems specifies the dimensions, tolerances, and designation codes for O-rings used in fluid power systems. This standard is part of the ISO 3601 series, which is a comprehensive set of guidelines for O-rings that are used in […]