
Regulatory Science, Design Controls & Medical Device Development
Professional Certificate
Program Overview
The Professional Certificate in Medical Device Development, Design Controls & Regulatory Science program is designed to prepare scientists, engineers, and innovators to bring life-changing medical devices from concept to market. Participants will gain a working knowledge of FDA regulations, ISO standards, and best practices across the device development lifecycle from design planning, verification, and validation through regulatory submissions and quality management systems (QMS).
The Program Is Ideal For
- Early-stage researchers and engineers
- Industry professionals seeking regulatory expertise
- Entrepreneurs and innovators preparing devices for FDA approval and commercialization
Upon completion, participants will be prepared to meet the growing demand for regulatory and design-control expertise in the global medical device industry.
Course Descriptions
This course provides a comprehensive understanding of the FDA’s Design Control requirements (21 CFR 820.30) and ISO 14971 risk management. Topics include:
- Design planning and feasibility analysis.
- User needs and design inputs/outputs.
- Design verification and validation (V&V).
- Risk management planning (FMEA, hazard analysis).
- Design history file (DHF) and documentation best practices.
- Change control and design transfer.
- Post-market design considerations.
Participants will learn how to navigate the U.S. FDA regulatory framework, including:
- Device classification and regulatory controls.
- Submission pathways (510(k), De Novo, PMA, HDE).
- Preparing regulatory submissions (eSTAR/eCopy).
- Pre-Submission (Q-Sub) meetings and FDA interactions.
- IDEs and clinical study requirements.
- Post-market obligations, labeling, advertising, and promotion.
- Hot topics (AI/ML, digital health, combination products).
This course explores how to implement and maintain a compliant QMS in line with FDA, ISO 13485, and EU MDR requirements. Coverage includes:
- Document and record control (electronic and paper systems).
- Supplier qualification, purchasing controls, and audits.
- Production and process control, validation, and inspections.
- Corrective and preventive actions (CAPA).
- Complaint handling, recalls, and post-market surveillance.
- Internal and external audits, management review, and audit preparedness.
Meet Our Instructors

Karrer Alghazali, Ph.D.
Program Director
Assistant Professor, Electrical & Computer Engineering
New York Institute of Technology
Karrer Alghazali earned his Ph.D. in Applied Science at University of Arkansas at Little Rock and has expertise in regenerative medicine, advanced biomaterials, exosome therapeutics, and medical device development. With over eight years of biomedical industry experience, Alghazali has been the primary investigator on multiple NIH-funded projects and inventor on patents in tissue engineering and medical devices, successfully transitioning medical devices from concept to technology maturation. An assistant professor at New York Tech, he currently leads the university’s Next Gen Tissue Engineering and Advanced Materials (TEAM) Lab, focusing on translational research bridging material science and device regulation.

Christine Scifert
Founder & Partner, MRC Global
Christine Scifert specializes in regulatory strategy and quality systems for medical devices, helping companies expedite market entry using risk-based approaches. Before founding MRC Global in 2020, Scifert was executive vice president at MRC/X, LLC from 2016-2022, and was managing partner at Memphis Regulatory Consulting from 2009-2016. Before that, she spent nine years at Medtronic Spinal and Biologics as director and senior director of regulatory affairs, where she managed global regulatory submissions and compliance, developed and implemented design control processes, and conducted due diligence for acquisitions.
Scifert earned her MEM in Engineering Management at Christian Brothers University, has an M.S. in Biomedical Engineering from University of Iowa, and a B.S. in Physics from Hamline University. She is an adjunct professor teaching regulatory affairs at Christian Brothers University.

Adam Jakus, Ph.D.
Industry Advisor
Founding CEO of BioThera 3 Advising & Consulting;
CEO PRO Therapeutics
Adam Jakus is a mentor, advisor, and executive-in-residence to numerous national medtech/biotech/life-science entrepreneurial and commercialization programs. He is a champion of the biofabrication and tissue engineering industry and actively supports new founders and young companies that are bringing innovative technologies to market.