Yuanyuan Yang Email and Phone Number

AI medical software quality assurance ＆ regulatory submission & clinical study in China&US&EU&Japan.

1. Develop China pre-market regulatory registration strategy and plan for imported and domestic ECG/Anesthesia/Ventilator products. 2. Lead and drive China pre-market registration activities (Draft product technical requirements, Type testing, Clinical evaluation, Preparation for submission files) for ECG/Anesthesia/Ventilator products (including standalone software registration and active medical device registration).3. Establish and maintain relationship with CFDA testing lab (Beijing, Shanghai, Guangzhou) to ensure the CFDA type testing is proceeded smoothly.4. Support the CFDA QMS inspection at manufacturing site during CFDA registration process. 5. Provide the regulatory support to China market & sales & service team. 6. Provide regulatory training to global engineering team to ensure the product compliance with China regulations and standards. 7. Review the changes including labeling changes to determine the need of license updates, and make sure the product compliance of China regulations.8. Support China post-marketing RA team to resolve post-marketing issues.

Lead safety and regulatory compliance for CT NPI program. Ensure product compliance with applicable international laws, regulations and standards. Conduct safety tests to verify the safety compliance between design output and input. Lead risk management project team to complete the risk management activities(risk analysis, risk evaluation, risk control etc.) according to ISO 14971, establish & maintain the Risk Management File for all CT products during whole lifecyle. Establish and maintain relationship with the 3rd party testing labs, and lead the 3rd party safety and regulatory tests for product safety certification and regulatory submission, such as ITS (Intertek Testing Services), UL, CSA, KFDA and CFDA/CCC (LMTI). Coach design engineers about safety and regulatory requirements, risk management process, FMEA to ensure product quality and compliance. Lead the implementation for new regulations or new standards Prepare and support internal/external audit, such as FDA, CE, CMD, ETL, INMETRO, China CQC.

Describe your position

1. Provide the Conceptional Team with the necessary safety and regulatory requirements at the conceptual stage. 2. Be responsible for Safety design of PC desktop systems, co-working with functional teams to ensure that the product design can meet safety and regulatory requirements. 3. Perform safety verification test according to corporation safety testing procedure and international safety standards, safety issue debugging and problem resolution leadership and providing solutions on schedule. 4. keep tracking of project certification status to ensure all certifications can be completed as planned. 5. Perform worldwide safety certification for PC product, Prepare safety technical files and critical components list for UL engineer. 6. Maintain documentations of safety lab according to ISO 17025

1. Be responsible for Safety design of PC desktop systems, co-working with cross-functional teams to ensure that the products are designed with the necessary provision for passing safety and regulatory tests. 2. Work out EMC and Safety Certification schedule, Keep tracking of project certification status to ensure all certifications can be completed as planned. 3. Prepare technical files for Agency to apply EMC and Safety certification. 4. Review EMC and safety test reports, including formal Compliance test reports.

Project Management Engineer Be responsible for management of Environmental and Reliability test, EMC/safety test and Certification for new PC products. Responsibilities: 1. Work out project development test schedule 2. Coordinate with other Functional teams to resolve communicating problem and technical issues. 3. Prepare and keep tracking of project status to ensure project run smoothly as planned. 4. Support EMC and safety Engineer to complete certification work on schedule.