Technical File Preparation for EU MDR (European Union Medical Device Regulation)
What is EU MDR? The EU Medical Device Regulation (MDR), formally known as Regulation (EU) 2017/745, governs the medical device market in the European Union. The MDR sets out the requirements for the design, manufacture, and sale of medical devices within the EU. It ensures that manufacturers place devices on the market only after proving […]
ISO/IEC 42001:2023 – Artificial Intelligence Management System
What is ISO/IEC 42001:2023 – What is this Standard? ISO/IEC 42001:2023 is the world’s first international standard that specifies requirements for a management system for artificial intelligence (AI). Developed by ISO and IEC, this groundbreaking standard provides organizations with a structured framework to govern, manage and deploy AI systems responsibly, ethically and effectively. ISO/IEC 42001 addresses organizational governance, […]
ISO 15189:2022 (Medical laboratories) Lead Auditor Training
What is ISO 15189:2022 Lead Auditor Training? ISO 15189 Lead Auditor Training is a specialized course designed for individuals who wish to develop the expertise to audit Medical Laboratories’ Quality Management Systems (QMS) against the ISO 15189 standards. This training is crucial for professionals involved in the auditing, maintaining, or supervising of the management systems […]
GDPR – General Data Protection Regulation
What is General Data Protection Regulation (GDPR)? The General Data Protection Regulation (GDPR) is a European Union law focused on data protection and privacy for individuals within the EU and the European Economic Area (EEA). It was adopted in April 2016 and came into force on May 25, 2018. GDPR governs how organizations collect, process, […]
ISO 45001 Lead Auditor Training
Become a Certified ISO 45001 Lead Auditor and Promote Workplace Safety Workplace safety and employee well-being are critical components of any successful organization. With increasing global emphasis on occupational health and safety, the demand for qualified safety auditors is on the rise. ISO 45001 Lead Auditor Training is a comprehensive course that equips professionals with […]
PCI DSS (Payment Card Industry Data Security Standard)
What is PCI DSS? The Payment Card Industry Data Security Standard (PCI DSS) is a set of security standards created to ensure that all organizations that handle cardholder data maintain a secure environment. Established by the Payment Card Industry Security Standards Council (PCI SSC), It aims to protect credit card information from theft and fraud […]
ISO 15489-1:2016 Records Management
What is ISO 15489-1:2016 Records Management? ISO 15489-1:2016 is an internationally recognized standard developed by the International Organization for Standardization (ISO). It establishes a systematic approach for managing records and documenting processes, decisions, transactions, and communications within an organization. This standard outlines principles and concepts necessary for effective records management and helps ensure that authentic, […]
ISO/IEC 27035-1:2023 – Information Technology: Information Security Incident Management
What is ISO/IEC 27035-1:2023? ISO/IEC 27035-1:2023 is the foundational part of the ISO/IEC 27035 series, providing principles and a general framework for managing information security incidents. In today’s digital environment, organizations face an ever-increasing range of cyber threats, from malware and phishing to insider threats and data breaches. This standard enables organizations to respond effectively […]
ISO/IEC 27032:2023 Cybersecurity — Guidelines for Internet Security
What is ISO/IEC 27032:2023? ISO/IEC 27032:2023 provides guidelines for enhancing cybersecurity specifically focused on Internet security. This standard helps organizations address the security concerns related to the use of the internet and the interconnection of information systems across various platforms. It offers guidance on how to improve protection against cyber threats and secure internet-based interactions, […]
ISO 14001 Lead Auditor Training
Master Environmental Auditing with ISO 14001 Lead Auditor Training In today’s eco-conscious world, organizations must not only comply with environmental regulations but also demonstrate a proactive approach to sustainable business practices. ISO 14001 Lead Auditor Training equips professionals with the knowledge and skills to audit environmental management systems (EMS) effectively in accordance with the ISO […]
