Rosewinter Kodzwa M.

US/International Standards - Conformity Assessment for US National Standards & Personnel Certification (AAMI, ANSI, ANAB, ISO, IEC Standards & Accreditation).

Role
Director Standards at Aami
Location
Alexandria, VA, US
LinkedIn followers
500 followers
General Business & ManagementView LinkedIn profile

About Rosewinter Kodzwa M.

My collective work experience falls into 5 major skills - 1. Regulatory compliance as a US and international healthcare technical standards manager and American College of Radiology (ACR)/Centers for Medicare & Medicaid Services (CMS) federal hospital lead surveyor of radiology departments. Clinical as a certified MRI technologist. Professional development and continuing education compliance for both physicians and technologists. Consulting and advisory as an MRI technologist legal expert witness, operations and strategic planning and execution. ANSI standards development and ANAB ISO/IEC 17024 personnel standard credentialing for trade associations in electrical testing and elevator contractors/inspectors.Have 12 years clinical experience as an MRI technologist at world class facilities such as Duke and Mayo Clinic Health systems. 5 years’ hands-on surveyor experience as a lead auditor on hospital inspections with a radiologist and medical physicist team representing ACR accreditation as contracted by CMS federal compliance. I regularly briefed CEOs and other executives in survey readiness, exit interviews, guiding through deficiencies and approving Corrective Action Plans (CAPAs). Consulted as a legal MR technologist expert witness for attorneys which helps mitigate risk. FDA Medical Devices I Frequently Operated• FDA class I devices such as MR room wheelchairs, oxygen tanks, infusion pumps, BP monitors, catheters, and blood collection kits.• FDA Class II MRI scanning medical devices 1.5 and 3.0 Tesla machines, Angiographic power injectors, ECG machines and pulse oximeters.• FDA class medical devices such as pacemakers, AED’s, telemetry, breast implants and biopsies. Have 9 years’ experience researching State and Federal regulations and helping interpret them for compliance. Perform technical reviews, research, and write healthcare compliance professional published articles. 7 years’ experience with US and Canadian healthcare standard setting. I was co-chair to a technical committee for Health Standards Organization (HSO)/Accreditation Canada, writing best practice healthcare standards for HSOs Canadian and global accreditations. I am an HSO Leading Practices Reviewer.Have 5 years’ experience reviewing physician (ACR) continuing medical education (CME) and technologist [American Society of Radiologic Technologists (ASRT)] continuing education (CE) for compliance.Have 3 years facilitating exam, safety & training committees, ANSI standard revisions for electrical testing technician and ANAB elevator contractor certifications.

Experience

  1. Director Standards

    Aami

    Mar 2024 — Present · Arlington, VA, US

    I work closely with and provide oversight as appropriate to committees and working groups in the development of national (AAMI, ANSI) and international (ISO/IEC) standards.

Education

  • Kirkwood Community College

    Associate's Degree, Business Administration and Management, General

    1996 — 1998

  • Liberty University

    Master of Business Administration (M.B.A.)

    2012 — 2014

  • Kirkwood Community College

    Dietetics and Clinical Nutrition Services

    1999 — 2000

  • George Mason University

    Project Management Professional (PMP) Institutional Certification

    2015 — 2015

  • University of Iowa

    Bachelor of Science (BS), Radiation Sciences

    2001 — 2004

  • IATA Training

    Certificate, IATA/UFTAA Foundation in Travel & Tourism

    1991 — 1991

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Rosewinter Kodzwa M. — Director Standards at Aami in Alexandria, VA, US | Unifers