Participants will gain insights into:

• Key definitions and risk classification
• Prohibited AI practices
• Obligations of providers, deployers, authorized representatives, importers, and distributors
• Quality and Risk Management Systems, along with other compliance requirements
• Conformity assessment procedures
• Post-market monitoring and surveillance

Attendees will explore:

• The standard’s framework and fundamental principles
• Essential requirements for implementing an AI management system
• Practical guidance on achieving and maintaining compliance

Gain the knowledge to navigate:

• Essentials of AI and Machine Learning, including definitions, types, and key characteristics.
• Understand the full process, from design and development to deployment and monitoring, covering the entire AI system lifecycle.
• Insights into governance, risk management, security, privacy, transparency, and explainability for ethical AI deployment

The training offers a thorough look into AI fairness, enabling participants to explore methods for detecting, evaluating, and addressing bias in AI systems to foster ethical and equitable outcomes.

• Understand bias and fairness in AI systems.
• Learn to identify and assess bias in AI lifecycle.
• Explore methods for mitigating unwanted bias in development.
• Gain insights into challenges of addressing bias in real-world.
• Familiarize with ISO/IEC TR 24027:2021 standard implications.

This training covers challenges and best practices for testing AI systems, emphasizing their unique characteristics, rigorous testing needs, and techniques to ensure quality and reliability.

• Understand the unique parameters of AI systems and their implications for testing.
• Apply quality characteristics and define requirements for AI-based systems.
• Utilize various testing techniques, including black-box and white-box methods.
• Navigate testing challenges of self-learning and non-deterministic systems.
• AI testing guidance based on ISO/IEC TR 29119-11:2020 standard

Gain hands-on experience with proven methods to tackle AI challenges and build reliable, consistent products.

• Understand AI robustness by learning key concepts, definitions, and the importance of consistent performance.
• Explore diverse testing methods, including statistical, formal, and empirical techniques, to evaluate AI reliability.
• Develop expertise in evaluating AI performance with advanced metrics, ensuring the creation of reliable and trustworthy AI.
• Uncover the practical implications of ISO/IEC TR 24029 compliance

This training provides an overview of the EU Medical Device Regulation 2017/745 (MDR), covering key regulatory requirements, classification rules, conformity assessment procedures, technical documentation, post-market surveillance, and the role of economic operators. It is designed to help professionals understand compliance obligations and implement MDR requirements effectively within their organization.

This training provides a detailed introduction to EU In Vitro Diagnostic Regulation 2017/746 (IVDR) , covering key regulatory requirements, classification criteria, conformity assessment pathways, technical documentation, post-market surveillance, and the roles of economic operators. Participants will gain essential knowledge to support compliance and successfully implement IVDR within their organization.

Get an overview of key US FDA requirements for medical devices, focusing on the relevant sections of CFR Title 21, including Parts 820 (Quality System Regulations), 801 (Labeling), 803 (Medical Device Reporting), 806 (Corrections and Removals), 807 (Establishment Registration and Device Listing), and 810 (Medical Device Recall). Participants will gain a clear understanding of the regulatory obligations for compliance, ensuring safe and effective medical devices.

This training provides a comprehensive understanding of the Medical Device Single Audit Program (MDSAP), which enables manufacturers to meet the requirements of regulatory authorities in the USA, Canada, Brazil, Australia, and Japan through a single audit. Participants will gain insights into the MDSAP audit process, the specific requirements from each regulatory authority, and strategies for effectively preparing for and managing the audit.

ISO 13485:2016 is a globally recognized standard for quality management systems in the medical device industry. It defines requirements for stakeholders involved at every stage of the medical device lifecycle. Our tailored training provides an overview of the standard's key requirements and practical guidance on implementation, enabling you to develop effective strategies for compliance, product development, and market access.

Overview of IEC 62304:2006, the globally recognized standard for medical device software lifecycle processes. Participants will explore:

• The scope and structure of IEC 62304
• Software safety classification and risk-based methodologies
• Essential lifecycle processes: development, maintenance, risk management, configuration management, and problem resolution
• Practical application of the standard within an organizational framework.

This training offers a detailed introduction to the General Data Protection Regulation (GDPR) and its key principles. Participants will gain insights into:

• GDPR Overview – Purpose, scope, and applicability
• Core Data Protection Principles – Lawful processing, transparency, and accountability
• Individual Rights – Access, rectification, erasure, data portability, and more
• Organizational Responsibilities – Roles of data controllers, processors, and compliance obligations
• Data Breach Management – Notification requirements and incident response

Get a practical understanding of ISO/IEC 27001:2022 and more:

• Acquire the techniques to create and manage a tailored Information Security Management System (ISMS) that safeguards your assets.
• Learn how to identify, assess, and treat information security risks, and develop a risk management framework
• Explore the information security controls and how to implement them effectively.
• Master the ISO/IEC 27001:2022 certification process, including essential documentation, key audit steps, and proven strategies for achieving and maintaining compliance.

ISO 9001:2015 is an internationally recognized standard for quality management systems (QMS). It provides a framework for organizations to ensure consistent quality in products and services. This training session covers:

• The structure and key principles of ISO 9001:2015.
• Implementation strategies for effective quality management.
• Continuous improvement and compliance requirements.

This training provides a focused overview of ISO 19011:2018, specifically tailored to internal audits for management systems. Participants will learn:

• Key steps in planning, conducting, and reporting internal audits
• Core principles for effective internal auditing, including objectivity and evidence-based approaches
• Essential qualities and skills required for internal auditors
• How to apply risk-based approach to internal audits
• How to document findings and ensure corrective actions are taken

Automotive SPICE (ASPICE) is a process assessment model widely used in the automotive industry to evaluate software development processes. This training session covers:

• The ASPICE framework and its key process areas
• Capability levels and assessment methodology
• Practical implementation strategies for automotive software development
• Integration of Agile principles with ASPICE for more flexible and efficient processes