● Founder/General Manager/General Consultant of Rui Enni Consulting

● SGS/TUV/ITS Distinguished Lecturer

● SGS/DNV and DEKRA recommend consulting advisors

● Successfully held multiple seminars and training sessions in collaboration with Shenzhen Medical Device Quality Promotion Association, Dongguan Medical Association, and others;

● I have been working on medical device regulations since 2005 and have extensive experience in medical device registration, regulations, systems, and quality management

● Having years of senior management experience in medical device companies, familiar with the operational processes and business requirements of various departments in medical device companies

● Independently completed over a hundred projects including NMPA, CE, FDA 510K, MDSAP, and FDA factory inspections, and has maintained zero failed coaching and registration cases to date

● Practical experts in the medical device industry, integrating theory with practice to achieve a combination of knowledge and action

● Obtained 3 FDA 510K registered zero defect records and 5 FDA factory inspection zero defect records (with a minimum company of only 40 people)

● Rui Enni Consulting Partner/Deputy General Manager/Head of System&Training Department

● 16 years of experience in IVD/active/sterile medical device quality management system and consulting

● Previously worked for consulting firms such as Cell Biology, Medtech, Jenari, Gidis, and others in the same industry

● Over a hundred factory audit coaching services have been provided (C/B GMP, ISO13485, MDSAP, 21CFR211, QSR820), involving well-known listed companies, group companies, medical device enterprises, and small and medium-sized enterprises. Our products cover four major areas: active, sterile, interventional, and IVD, with no failure cases.

● Familiar with the product registration and system of medical devices, including active, sterile, interventional, in vitro diagnostic and other fields.

● Have solid knowledge in medical device production quality management, laws and regulations, and other related areas

● Proficient in ISO13485, QSR 820, BGMP, MDR&IVDR, MDSAP, NMPA and other requirements

● Familiar with clean room management, pure water testing and microbiological testing technology, EO sterilization confirmation, packaging expiration date confirmation, safety EMC, software confirmation, design and development, risk management, process control, CAPA and other fields.

● Bachelor's degree in Biomedical Engineering

● Technical Director of Registration Department

● 15 years of experience in active medical device registration and certification;

● Previously worked for medical device companies such as Aiole, Dongdixin, and Bangjian, responsible for domestic and international registration projects of medical devices;

● During my employment, I have been responsible for more than ten types of medical devices for measuring body temperature, blood pressure, blood sugar, electrical stimulation, ultrasound, blood oxygen, electrocardiogram, oxygen generator, nebulization, and physical therapy; Successfully completed nearly a hundred NMPA, CE, and FDA registration projects;

● The CE project that has been completed has received praise from NB, breaking its record for the fastest certification process.

● Doctorate in Clinical Medicine at the University of Munich in Germany

● Master of Medicine and Surgery, University of Pavia, Italy

● Registered practicing physicians specializing in general surgery, visceral surgery, and transplant surgery

● Responsible for organizing, coordinating, and managing clinical trial matters in the European Union

● Proficient in German, Italian, English, and Chinese, with years of experience in practicing medicine in the European Union

● Has published multiple SCI papers and is familiar with the requirements of China, the European Union, the United States, and ICH-GCP