Yutaka Ikeuchi
Senior Regulatory Affairs Specialist at Siemens Healthineers
Based in Tokyo, Japan
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Seniority
Manager
Department
Healthcare & Human Services
Location
Tokyo
Industry
Hospitals and Health Care
Company size
49K
Contact information
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y•••••••@siemens-healthineers.com
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Background
About Yutaka Ikeuchi
Regulatory Affairs Accomplished experience of regulatory affairs for medical device in Japan from August 2002 -Contributes to obtaining approval of many Class and IV medical devices in Japan -Experience with Class Medical Device Design Examination Certification under the Medical Device Directive -Specialty product fields: Vascular catheters, gastrointestinal catheters, sterilized products, medical electrical equipment, medical devices as software including Artificial intelligence and Computer-aided detection 2. Quality Assurance -Operation management of the quality management system from January -QMS Ministerial Ordinance in Japan -ISO 13485 -MDD Annex II -KGMP (MFDS)
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