Focusing on compliance and cutting-edge technology in the medical device field
Over ten years of experience in the medical device industry, skilled in providing compliance consulting services, and interested in web applications development. Committed to improving the automation of compliance processes, tracking the latest AI technology, and applying it to various aspects of medical device compliance.
Compliance automation - Improving efficiency
Automation technology is changing the way compliance work is done. We can use machine learning and artificial intelligence to analyze large amounts of data and automatically generate documents and reports. This way, we can perform audits and submit declaration materials more quickly.
We can also use automation tools to monitor and track changes in compliance requirements. This way, we can more quickly identify and fix problems and ensure that our declaration materials always meet current standards. By using automation technology, we can more efficiently complete compliance work and save time to focus on other essential tasks.
What can automation technology do
Committed to improving compliance work and document preparation efficiency through automation technology.
Rapid documents
Quickly generate fixed format TDs through templates, materials, etc. such as administrative information, overview information, and some content of V&V.
Simple submissions
For projects such as renewal registration, simple registration changes, change filing, and change notification of IFU, quickly generate complete TDs by inputting key information.
Navigator
For content that cannot be easily template-ized, such as risk management and various pre-clinical studies, provide standard, internationally accepted, and technologically current guidelines as reference to achieve workflow-based non-clinical verification.
State-of-the-art
Using AI technology to continuously update the existing technology levels of various medical devices and their diagnostic / treatment of diseases, available for SOTA evaluation during the clinical evaluation process, as well as a reference in the clinical research process.
CER
In accordance with the requirements of the NMPA and EU MDR, use AI and automation technology to clearly link clinical evidence to product claims, risk management, product design, and post-market activities, and quickly form evaluation reports.
How to achieve automation
Automation can be achieved through the implementation of web-based applications. This approach has many advantages, as it is cross-platform and can be used on various devices.
Web App
Web application development also has a high level of security, ensuring data integrity and security. In compliance work and preparing submission materials, automation technology is necessary, and it can improve efficiency, reduce human errors, and be more in line with regulatory requirements.
If you are interested in automation, you are welcome to talk.
ABOUT ME
一个不断折腾的非主流RA