Designing Safe And Effective Medical Devices with Zakiyyah Walker, WSE '00 (BME)

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Designing Safe And Effective Medical Devices
Instructor: Zakiyyah Walker, WSE '00 (BME)
October 20 - November 10 (4 Sessions)
Tuesdays, 7:00PM - 9:00PM ET
Virtual via Zoom

Brought to you by Odyssey

Course Description: Medical devices play a vital role in modern healthcare, from diagnostic tools and monitoring systems to life-saving implants. But how are these products developed to ensure they are both safe and effective for human use? This course introduces the principles of Design Controls as defined in FDA QMSR, the regulation for medical devices sold in the United States and ISO 13485:2016, the international standard governing quality management systems for medical devices. Participants will explore the history and purpose of Design Controls, the regulatory landscape surrounding medical devices, and the role of risk management throughout product development. Through real-world examples, the course examines how medical device companies apply Design Control requirements integrated with risk management to deliver medical devices safely from concept to patient use.

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Johns Hopkins Tuition Remission Policies

Tuition benefits are available to University faculty, staff, and retirees only. Employees of Johns Hopkins Hospital, Johns Hopkins Medical Institutions, or the Applied Physics Laboratory should contact your institution’s Human Resources office for information about tuition remission and eligibility:

Johns Hopkins Hospitals and Medical Institutions: https://www.hopkinsmedicine.org/human-resources/benefits/tuition-assistance
Johns Hopkins Applied Physics Laboratory: https://www.jhuapl.edu/careers/professional-development

Select the correct ticket pricing during registration. If we cannot confirm your university eligibility, you will be requested to pay the full registration price for each course. Complete eligibility details can be found here.

Withdrawals & Refunds:

If a course is canceled or closed, the registrant is notified immediately, and a full refund is processed automatically unless another course is requested. Registrants who wish to withdraw from an active course must complete the online Odyssey Refund Request Form. Attach any documentation to support your request (e.g., medical documentation, family crisis documentation, etc.).

100% refund: Prior to the start of the course and after the first class.
No refunds: After the first week of each course unless in exceptional cases.

For single-session courses:
100% refundable within two (2) business days of the event.

Please note, refunds apply only to the tuition portion of an Odyssey participant’s charges and are not applicable to any fees or gifts made to the Johns Hopkins Alumni Association. Registrants will be notified by email if a refund is approved within five (5) business days.

ABOUT Zakiyyah Walker, WSE '00
Odyssey Instructor

Zakiyyah Walker is a graduate of The Johns Hopkins University with a Bachelor of Science in Biomedical Engineering from the Whiting School of Engineering from the class of 2000; receiving her diploma in 2001 to include a certificate for a 2nd major in Materials Science & Engineering the following semester. She is a Design Assurance Leader with 24+ years of experience in the Medical Device Industry. Zakiyyah’s career has been shaped by three Medtech Big 100 companies such as Smith and Nephew Orthopaedics, Stryker Spine and Becton Dickinson MDS. Zakiyyah began her career at Smith and Nephew Orthopaedics in Memphis,TN as a Sr. Research Test Engineer and obtained her Masters in Mechanical Engineering from the University of Memphis. Her career journey continued at Stryker Spine located in Allendale, New Jersey. She served as Division Design Controls process owner and Testing Lead for New Product Development and Design Changes. Zakiyyah then transitioned to Becton Dickinson MDS where she defined and harmonized its Design Controls process, created best practices and trained global cross functional teams. She also served as their Design Controls process owner. Zakiyyah was born and raised in NJ and currently resides there with her toy poodle Midnite.

Event Date
Starts:
Tuesday, October 20, 2026
7:00pm EDT

Ends:
Tuesday, November 10, 2026
9:00pm EDT

Contact
Odyssey
Alumni Relations Lifelong Learning
800-JHU-JHU1 (548-5481)
odyssey@jhu.edu

Ticket Options

	General Registration	$
	JHU Alumni (all divisions) 50% discount. Alumni status will be confirmed.	$
	Johns Hopkins University Faculty, Staff, or Retiree 80% discount. Employment status will be confirmed.	$
	Johns Hopkins University Spouse or Domestic Partner 50% discount. Employment status of Spouse/Domestic Partner will be confirmed.	$

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Select your registration type

General Registration ($200.00)

JHU Alumni (all divisions) ($100.00)

Johns Hopkins University Faculty, Staff, or Retiree ($40.00)

Johns Hopkins University Spouse or Domestic Partner ($100.00)

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Designing Safe And Effective Medical Devices with Zakiyyah Walker, WSE '00 (BME)

Johns Hopkins Tuition Remission Policies

Johns Hopkins Hospitals and Medical Institutions: https://www.hopkinsmedicine.org/human-resources/benefits/tuition-assistance

Johns Hopkins Applied Physics Laboratory: https://www.jhuapl.edu/careers/professional-development

Select the correct ticket pricing during registration. If we cannot confirm your university eligibility, you will be requested to pay the full registration price for each course. Complete eligibility details can be found here.

Withdrawals & Refunds:

100% refund: Prior to the start of the course and after the first class.

No refunds: After the first week of each course unless in exceptional cases.

For single-session courses:
100% refundable within two (2) business days of the event.

Please note, refunds apply only to the tuition portion of an Odyssey participant’s charges and are not applicable to any fees or gifts made to the Johns Hopkins Alumni Association. Registrants will be notified by email if a refund is approved within five (5) business days.

Registration Information

Make a Gift

Payment Information

Designing Safe And Effective Medical Devices with Zakiyyah Walker, WSE '00 (BME)

Johns Hopkins Tuition Remission Policies

Johns Hopkins Hospitals and Medical Institutions: https://www.hopkinsmedicine.org/human-resources/benefits/tuition-assistance

Johns Hopkins Applied Physics Laboratory: https://www.jhuapl.edu/careers/professional-development

Select the correct ticket pricing during registration. If we cannot confirm your university eligibility, you will be requested to pay the full registration price for each course. Complete eligibility details can be found here.

Withdrawals & Refunds:

100% refund: Prior to the start of the course and after the first class.

No refunds: After the first week of each course unless in exceptional cases.

For single-session courses:100% refundable within two (2) business days of the event.

Please note, refunds apply only to the tuition portion of an Odyssey participant’s charges and are not applicable to any fees or gifts made to the Johns Hopkins Alumni Association. Registrants will be notified by email if a refund is approved within five (5) business days.

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Make a Gift

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For single-session courses:
100% refundable within two (2) business days of the event.