Yu Lun (Evita) Chen Email & Phone Number

Taipei, Taiwan

• Led a cross-functional team of regulatory registration, obtaining FDA professional-use 510k clearance (k192369) within 3 months• Initiated POC testing A1c IVD medical device FDA CLIA Waiver regulatory application, Organized a cross-functional team including clinical research, APP function, and algorithm, analyzed clinical data of method Comparison for FDA CLIA Waiver application• Analyzed target countries' regulation requirements and preparing accurate documentation to support regulatory activities for international customer• Coordinated with the notified body and authorities to maintain regulatory compliance• Aided company's quality system compliance with MDSAP regulatory, achieving MDSAP certification• Upgraded medical device knowledges on the latest worldwide regulations/standards, especially focused on IVD regulations/standards, e.g. In Vitro Diagnostic Devices Regulation (IVDR), Clinical & Laboratory Standards Institute (CLSI)

Taipei, Taiwan

• Collaborated with National Taiwan University Hospital(NTUH) surgical, rehabilitation and thoracic medicine team to develop 5 innovative medical devices, 3 medical devices were successfully developed and are in the market (AmCAD-UT, AmCAD-UO, AmCAD-US)• Plan at least 3+ product development roadmap, market assessment, regulatory strategy, patient arrangement, and clinical study, implementing to marketing in three years• Organized budgets of product development, resulting in at least 90% of expenses successfully estimated in budget planning• Controlled multiple interrelated projects (3-5 simultaneously), managed 80% performance of all tasks over time, with elaborate cross-functional teamwork• Coordinated with Good Manufacturing Practices (GMP) manufacturing partner, conducted new product design, reducing interventional therapy operation time

Taipei, Taiwan

• Led at least 3 innovative medical devices registration, prepare, submit, and manage regulatory submissions required for device approvals and registrations in the US FDA 510(k), CE Marking, NMPA(CFDA), TFDA and globally, gaining 6+ marketing approval to achieve company's worldwide regulatory strategies.• Oversaw company's quality activities and documentation groups in developing quality system, organized and successfully gained external quality system auditing approval, e.g. Good Manufacturing Practice (GMP) and ISO 13485:2016• Plan company's health insurance strategy, analyzed an innovative thyroid nodule ultrasound computer aided detection (CAD) medical device health insurance market access• Monitored design verification, pre-clinical, and post-market clinical studies by collaborating closely with at least 10 clinicians and medical professionals, to ensure the on-going safety and efficacy of products.• Upgraded medical device knowledges on the latest worldwide regulations/standards in compliance with MDD/MDR requirements

Taipei, Taiwan