Mary Vater
FDA 510k Consultant at Medical Device Academy, Inc.- Claim this Profile
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Topline Score
Bio
Shawn Westervelt, P.E.
Mary is a very detail oriented person who works very well independently or with loose supervision. Mary is eager to either lead or assist a team in obtaining the desired results. When given a task I could always count on Mary to deliver exceptional results on time.
Shawn Westervelt, P.E.
Mary is a very detail oriented person who works very well independently or with loose supervision. Mary is eager to either lead or assist a team in obtaining the desired results. When given a task I could always count on Mary to deliver exceptional results on time.
Shawn Westervelt, P.E.
Mary is a very detail oriented person who works very well independently or with loose supervision. Mary is eager to either lead or assist a team in obtaining the desired results. When given a task I could always count on Mary to deliver exceptional results on time.
Shawn Westervelt, P.E.
Mary is a very detail oriented person who works very well independently or with loose supervision. Mary is eager to either lead or assist a team in obtaining the desired results. When given a task I could always count on Mary to deliver exceptional results on time.
Credentials
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ICAgile Certified Professional
International Consortium for AgileNov, 2016- Nov, 2024 -
ISO 13485 Lead Auditor
Oriel STAT A MATRIXApr, 2015- Nov, 2024
Experience
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Medical Device Academy, Inc.
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United States
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Medical Equipment Manufacturing
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1 - 100 Employee
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FDA 510k Consultant
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Feb 2017 - Present
- FDA 510k Consultant specializing in FDA regulations and 510(k) submissions - Additional expertise in AI SaMD and medical device software development - Guide clients through the product development process in preparation for 510(k) submissions, prepare the final documentation package and eCopy for submission, participate in review process until device clearance - ISO 13485 Certified Lead Auditor, performing internal and supplier audits for client companies - Coach clients on effective risk management and design control practices - Develop and customize operating procedures in compliance with ISO 13485 and 21 CFR 820 Show less
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AAMI
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United States
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Non-profit Organization Management
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1 - 100 Employee
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Faculty
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Oct 2019 - Present
- Developed Lead Auditor, 510(k), and De Novo training courses for the non-profit organization founded to advance knowledge within the medical device industry. - Teach attendees compliant best practices in the areas of ISO 13485 and 21 CFR 820 auditing - Teach attendees about the 510(k) and De Novo Process. Explain the different sections of the submissions including the device description, substantial equivalence, electrical safety, EMC, biocompatibility, sterilization, software, animal testing, benchtop performance testing, and clinical testing. Show less
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Biomedical Devices of Kansas
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United States
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Medical Equipment Manufacturing
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1 - 100 Employee
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Head of Quality Assurance
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Jun 2014 - Jan 2017
- Responsible for Quality Assurance in compliance with ISO 13485, GLP, and FDA CFR 820 regulations- Tailored Quality Management System (QMS) to meet specific client applications - Facilitated QMS implementation and training for clients- ISO 13485 Lead Auditor Certified - Maintained Document Control system, and ensured good documentation practices were exercised- Built complaint management tool for improved traceability, monitoring, and data analysis
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Biomedical Engineer
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Aug 2013 - Oct 2016
- Assisted clients through the design planning, development, risk management and testing process in preparation for CE Mark and 510(k) submissions in the areas of electromechanical medical devices, mobile healthcare technologies, and injectable medical devices- Managed laser ablation research projects, specifically investigating the effects of various optical fiber tips on treatment profiles in cadaver breast tissue and other phantom materials
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Assistant Coordinator
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Aug 2011 - May 2013
- Developed programs and facilitated activities for middle school students to promote interest in science and engineering - Managed the SEEDS website - Processed electronic enrollments and handled the logistics of SEEDS events - Developed programs and facilitated activities for middle school students to promote interest in science and engineering - Managed the SEEDS website - Processed electronic enrollments and handled the logistics of SEEDS events
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Wichita State University
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United States
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Higher Education
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700 & Above Employee
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Research Assistant
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Aug 2010 - Jul 2011
- Designed protocol and ran experiments testing "lab on a chip" biodevices aimed at detecting inflammatory proteins - Analyzed collected data and assembled reports - Presented the research at the Undergraduate Research and Creative Activity Forum and Engineering Open House - Designed protocol and ran experiments testing "lab on a chip" biodevices aimed at detecting inflammatory proteins - Analyzed collected data and assembled reports - Presented the research at the Undergraduate Research and Creative Activity Forum and Engineering Open House
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Education
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2009 - 2013
Wichita State University
Bachelor of Science (B.S.), Bioengineering
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