Mike has over 30 years in regulatory affairs & quality assurance combined. He has over 8 years of that in medical device start-up companies dealing with spinal implants. His experience includes building ISO 13485 Quality Systems compliant to the US Code of Federal Regulations (FDA), the Canadian Standards (CMDCAS) & the Medical Device Directive for Europe (MDD). During his career, Mike has undergone audits performed by auditors, including the FDA and notified bodies like BSI, TUV, etc.. Some of his accomplishments at Aurora Spine include building, release and certification of the Company's ISO 13485 Quality System and achieving the CE Marking for the Company's first device, the ZIP MIS Interspinous Fusion System. He is a senior member of American Society for Quality (ASQ) where he holds certifications as both a Certified Quality Engineer (CQE) & Certified Biomedical Auditor (CBA) and sits on the ASQ-Temecula Section Board as Nominations Chair. Mike is also a member of the Regulatory Affairs Professionals Society (RAPS) and currently attends regulatory affairs courses at the University of California at San Diego (UCSD). Mike has over 30 years in regulatory affairs & quality assurance combined. He has over 8 years of that in medical device start-up companies dealing with spinal implants. His experience includes building ISO 13485 Quality Systems compliant to the US Code of Federal Regulations (FDA), the Canadian Standards (CMDCAS) & the Medical Device Directive for Europe (MDD). During his career, Mike has undergone audits performed by auditors, including the FDA and notified bodies like BSI, TUV, etc.. Some of his accomplishments at Aurora Spine include building, release and certification of the Company's ISO 13485 Quality System and achieving the CE Marking for the Company's first device, the ZIP MIS Interspinous Fusion System. He is a senior member of American Society for Quality (ASQ) where he holds certifications as both a Certified Quality Engineer (CQE) & Certified Biomedical Auditor (CBA) and sits on the ASQ-Temecula Section Board as Nominations Chair. Mike is also a member of the Regulatory Affairs Professionals Society (RAPS) and currently attends regulatory affairs courses at the University of California at San Diego (UCSD).

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