Empower Technical Capability

As the national society pays increasing attention to cybersecurity, the government has recently issued guiding documents, namely the "Guiding Principles for Network Security Registration and Review of Medical Device" (Revised in 2022). Medical device network security refers to the state where medical device products and related data are protected from unauthorized activities, and their confidentiality, integrity, and availability risks are at an acceptable level throughout the entire life cycle. Strengthening network security management and risk control in the process of new product development and lifecycle management is essential to ensure that medical device products are not subject to network attacks, information leakage, data theft or damage during use.

What we can do for you?

Provide relevant training on network security management processes to enable you to have basic network security awareness and learn how to conduct network security analysis of products.

We can assist you in developing and drafting network security-related plans, evaluations, risk management reports, Medical Device Safety Manufacturer Disclosure Statement (MDS2), etc.

Our consultants can directly participate in your product's network security risk assessment meetings, help you identify relevant network risks from multiple dimensions, and provide guidance, including product basic characters, data storage, data security, physical security, device/system updates, user access rights, and emergency access.

As the current network security situation becomes increasingly severe, medical device manufacturers need to pay special attention to the network security needs of their products. Especially in the early stages of a project, network security assessment can be carried out, and corresponding product requirements can be formed. A product network risk research report is required when submitting NMPA product registration. For products that require applications for EU MDR and US FDA, relevant network risk research reports also need to be submitted.

Medical regulatory agencies in various countries, including the EU,  FDA in US, and NMPA in China, are increasingly focusing on human factors engineering (HFE) and usability engineering (UE) validation and risk identification for medical device design and user manuals. On May 21, 2020, China's National Medical Products Administration (NMPA) released the "Guiding Principles for the Technical Review of Medical Device Design Based on Human Factors Engineering (Draft for Comment)," indicating that the domestic attention to HFE/UE is increasing. Although it is still in the comment stage, it is expected to be formally issued soon. Currently, if your medical device product requires an MDR certificate from the EU or submission to the US FDA, relevant research reports need to be provided.

What we can do for you?

We provide training on HFE/UE design guidelines, which can help you quickly master the basic principles and methods of HFE/UE engineering by demonstrating numerous case studies. In the early stages of a project, we can identify and reduce the safety risks of product design.

Through our network of testers, we can help you recruit suitable testers to conduct relevant HFE/UE research and testing in simulated clinical environments.

Help you organize and execute HFE/UE testing and collect and organize all research data.

Our consultants can help you draft clinical simulation test plans for HFE/UE engineering and design test record forms.

Provide training for research testers according to product type requirements.

Help you complete Formative Evaluation Reports and Summative Evaluation Reports.

You can choose the services we provide based on the needs of your product design and registration. By introducing HFE/UE studies, you can reduce the safety risks of your new product and help you prepare relevant studies reports that meet MDR and FDA requirements.

ISO 14971, Medical Device Risk Management, is integrated throughout various stages of the medical device lifecycle. Medical device manufacturers have the responsibility to control the risks associated with their devices to an acceptable level. It is necessary to study the risks both in the event of failures and in normal operational states.

 

FMEA, which stands for (Potential) Failure Mode and Effects Analysis, is a systematic approach aimed at identifying and preventing potential problems. It involves evaluating potential failure modes, their impact on components, processes, or systems, and the likelihood of their occurrence. By identifying potential issues in advance, FMEA improves the quality, reliability, and safety of products/processes. FMEA is widely applied at different stages of the manufacturing industry's product lifecycle. There are two main types: Design FMEA and Process FMEA, which analyze risks related to product design and production processes, respectively. FMEA is a primary tool and method used in risk management.

What we can do for you？

We provide ISO 14971 medical device risk management training to help startups enhance their risk management capabilities.

We offer tool training for FMEA and provide examples to help understand how to use the tool effectively.

Our consultants can assist in guiding and drafting risk management plans and reports, as well as help establish risk management processes.

Our experts can also participate as third-party reviewers in discussions related to dFMEA and pFMEA, offering recommendations and suggestions.

You can choose from the above services based on your specific needs. Establishing a robust risk management process is crucial to ensuring the safety and reliability of your products. We hope that the experience of our consultants can assist you in identifying risks in advance and providing valuable input for product and process design during your product development and production processes.