Product Commercialization Model Introduction (1 hours) - Free

Includes the definition of product commercialization/product mid-life cycle management, introduces a typical product commercialization model, and introduces the objectives, key deliveries, and key activities of each stage according to the five stages of the product life cycle. In the process of introducing the model, it will also briefly introduce the V&V model, production verification preparation process, quality management practices, and comparison of product commercialization in medical software and medical devices.

 

Target: Suitable for newly appointed product commercialization project managers or friends interested in product commercialization

Purpose: Through this training, you can have a preliminary understanding of the product commercialization process, key activities, and key deliveries

 

Project Risk Management Training （2 hours）

The training will cover basic concepts such as risk definition and characteristics. It will also introduce potential risks in different functional areas at different stages of commercialization, as well as corresponding preventive and mitigation measures. Participants will also learn how to use a project risk registry to manage all project risks, and finally, explore some best practices in project risk management.

 

Target: Product commercialization project managers and R&D technical managers with some experience

Purpose: Through this training, you can gain a deeper understanding of the potential risks that exist at different stages of product commercialization and how to mitigate or avoid them.

 

Project Management （24 hours）

PMBOK is known as the bible of project management. We will study the ten knowledge areas, including scope management, time management, cost management, quality management, risk management, human resource management, communication management, procurement management, stakeholder management, and integration management, along with the methods and tools associated with them. Additionally, we will also cover the five process groups, which include project initiation, planning processes, execution processes, control and monitor processes, and closing processes. Throughout the training, numerous real-life cases will be presented to aid understanding and practical application.

 

Target: Junior project managers/supervisors with some project management experience and individuals interested in project management

Purpose: Through this training, you will systematically learn the 10 knowledge areas and 5 process groups described in the PMBOK, as well as the tools and methods used.

 

Application of ISO 13485 and NMPA GMP System for Medical Device Software Manufacturers - Basic (1 hour) - Free

The content is primarily based on the ISO13485/GMP quality system standards, covering basic concepts, essential elements, quality control and assurance, internal audits, and improvement. During the training, various case studies will be presented to help participants understand the key aspects of quality system management.

 

 

 

Target: Suitable for personnel involved in medical device quality management, including quality control personnel, process quality assurance personnel, and research and development personnel.

Objective: Through this training, you can gain a preliminary understanding of the basic concepts, core elements, and basic methods and tools used in the ISO13485 and NMPA GMP quality systems. It aims to enhance quality awareness and enable adherence to these systems in your work.

 

Application of ISO 13485 and NMPA GMP System for Medical Device Software Manufacturers - Advanced (8 hours)

The content is primarily based on the ISO13485/GMP quality system standards, covering basic concepts, essential elements, quality control and assurance, internal audits, and improvement. This course is an advanced level and will incorporate examples to help participants understand regulatory requirements and practical implementation methods.

 

Target: Suitable for personnel involved in medical device quality management, including quality control personnel, process quality assurance personnel, and research and development personnel.

Objective: Through this training, you will gain a comprehensive understanding of the basic concepts and core elements of the ISO13485 and NMPA GMP quality systems. You will also learn how to use essential methods and tools in quality management.

 

 

IEC 62304 Medical Device Software Lifecycle and IEC 82304 General Requirements for Health Software Products Safety - Basic (1 hour) - Free

This course will primarily focus on introducing the basic concepts, core elements, and related content of the IEC 62304 medical device software lifecycle and the IEC 82304 general requirements for health software product safety. You will learn about the different stages of medical device software development, including requirements analysis, design, verification, and validation. Additionally, you will gain an understanding of the safety requirements for health software products and relevant regulations. The course will provide case studies and examples to help you better understand the practical application of the medical device software lifecycle and the general requirements for health software product safety.

 

Target: Relevant personnel involved in medical device quality management, including quality control personnel, process quality assurance personnel, R&D personnel, etc.

Objective: Through this training, you will gain a preliminary understanding of the medical device software lifecycle.

 

IEC 62304 Medical Device Software Lifecycle and IEC 82304 General Requirements for Health Software Products Safety - Advanced (8 hours)

This course is an advanced-level training that will focus on introducing the basic concepts, core elements, and related content of the IEC 62304 medical device software lifecycle and the IEC 82304 general requirements for health software product safety. You will delve into the various stages of medical device software development in detail, including requirements analysis, design, verification, validation, configuration management, and risk management. Additionally, the course will explore the safety requirements, data privacy protection, and compliance considerations specific to health software products. Through practical case studies and examples, you will be able to gain a comprehensive understanding of the practical application of the medical device software lifecycle and the general requirements for health software product safety.

 

Target: Relevant personnel engaged in medical device quality management, including quality control personnel, process quality assurance personnel, R&D personnel, etc.

Objective: Through this training, you will gain an in-depth understanding of the principles for the independent software technical review of medical devices.

 

Guidance Principles for Independent Software Technology Review in Medical Devices (4 hours)

This course will primarily focus on introducing the basic concepts, core elements, and related content of the principles for the independent software technical review of medical devices. You will learn about the importance of independent software technical review in medical device quality management. The course will cover the processes and steps involved in the independent software technical review of medical devices, including preparation of application materials, evaluation of review criteria, and review of technical documentation. Additionally, the course will discuss the regulatory requirements and compliance considerations related to independent software for medical devices. Through case studies and practical exercises, you will be able to better grasp the principles for the independent software technical review of medical devices and apply the knowledge gained in your practical work.

 

Target: Relevant personnel engaged in medical device quality management, including quality control personnel, process quality assurance personnel, R&D personnel, etc.

Objective: Through this training, you will gain an in-depth understanding of the principles for the independent software technical review of medical devices.

 

 

Clinical Trial Management (2 hours)

This training course will focus on the core knowledge and processes of medical device clinical trial management. You will learn essential aspects such as the fundamentals of clinical trial design, execution, supervision, and data analysis. The training will cover topics including ethics and compliance, trial safety monitoring, data management, and quality control. Through case analysis and experience sharing, you will comprehensively grasp the importance of clinical trial management and be able to apply the knowledge flexibly in your practical work, ensuring trial safety, quality, and compliance. We look forward to your participation in collectively elevating the professionalism of medical device clinical trial management!

 

 

Target: This training is suitable for sponsors (medical device companies) who need to understand project management and operations related to CRO/SMO, as well as individuals aiming to enhance their clinical trial management capabilities and knowledge.

Purpose: Through this training, you will gain a preliminary understanding of the basic processes and project management experience involved in clinical trials. You will be better equipped to select and collaborate with CRO/SMO companies.

 

Human Factor Engineering / Usability Design Guidance (1.5 hours)

The training will cover the basic concepts, principles, verification and validation methods of human factors engineering/usability engineering. It will also introduce the ten basic elements through case analysis, as well as other considerations, including clinical trials, imported medical devices, off-the-shelf user interfaces, and combination use, etc.

 

Target audience: Hardware and software R&D engineers, technical writers, and user experience designers for appearance design, etc.

Purpose: Through this training, you will learn about the principles of human factors engineering/usability design through numerous case studies, and apply them to the design and risk analysis process of products.

 

 

Cybersecurity Risk Management Process (1.5 hours）

The training will cover the basic concepts of network security, the basic process of network security risk management, role and responsibility definitions, as well as all network security-related activities and key deliveries throughout the product lifecycle. Finally, you will learn about the risk characteristic checklist to help you analyze and evaluate network security risks of products from different aspects

 

Target audience: Software R&D engineers and friends interested in network security risks.

Purpose: Through this training, you will learn about the basic process of network security risk management and how to perform risk analysis based on a risk characteristic checklist.

 

 ISO 14971 Medical Device Risk Management (8 hours)

This course will focus on introducing the basic concepts, core elements, and related content of ISO 14971 medical device risk management. You will learn about the importance of medical device risk management and its role in quality management. The course will cover the processes and steps involved in medical device risk management, including risk assessment, risk control, and the validation of risk assessment and risk control measures. Additionally, regulatory requirements and compliance considerations related to the ISO 14971 standard will be discussed. Through case studies and practical exercises, you will be able to better grasp the ISO 14971 standard for medical device risk management and apply the knowledge in your day-to-day work. This will help you effectively manage the risks associated with medical devices and ensure the safety and quality of your products.

 

Target: Quality management personnel, R&D personnel, production personnel, and other professionals involved in risk management in the medical device industry.

Objective: Through this training, you will gain a comprehensive understanding of the ISO 14971 standard for medical device risk management.