John Bai

WORK HISTORY

ABOUT JOHN BAI

Leveraging an education background in both electrical engineering and biomedical engineering, John Bai is a dedicated professional to the medical device industry. With an entrepreneurial mindset, he has been actively involved in many different aspects of the medical device development cycle including marketing, design, manufacturing, quality assurance, preclinical studies, and clinical trials. He seeks challenges to serve and lead a team in creating innovative designs for medical products that cater to market needs and clinical efficacy. He is actively involved in global medical device markets, both in developed markets such as the US and the EU, as well as emerging markets such as China and Brazil in providing affordable healthcare solutions to the needy.Specialties: Medical Device Design and Development, Device market research, Clinical Evaluation, Quality Assurance, Embedded System Design, System Engineering, Computer VisualizationProduct Expertise:Ophthalmic equipment: LCS surgery, Ocular Surface Disease treatment devices Electrosurgery: Harmonic scalpel, Bi-polar Vessel Sealer, Advanced energy surgical systemOrthopedics: Depuy\'s Hip and Knee productsActive Device: Negative pressure wound therapy (NPWT) pump, Sequential Compression Therapy devices, DVT Prevention TherapyDisposables: PU wound dressing, Epidural Syringes, Dental SyringesQuality Assurance/Regulatory Affairs:Design Control: DHF, DMR, DHR; Software lifecycle development per IEC 62304Quality system: ISO 13485, 21 CFR 820, GMP, CMDCAS, MDD (93/42/EEC)Regulatory: FDA 510(k), PMA, Europe: CE Certification, Brazil: ANVISA registration, China: CFDA registrationComprehensive experience in: IEC 60601-1:2005 Medical Electrical Equipment Safety, IEC60•••12:2007 Electromagnetic Compatibility, IEC60••••11:2010 Home Use IEC 62304 Software Lifecycle, ISO10993 Biocompatibility, ISO14971:2007 Risk ManagementMEDDEV 2.7.1 Clinical Evaluation