Risk Management and Design Controls for Medical Devices and IVDs

This instructor-led, three-day course covers design control principles relative to U.S. 21 CFR Part 820, ISO 13485:2016, the EU MDR/IVDR, and key elements of ISO 14971:2019. It provides a clear overview of essential medical device design control requirements and addresses common misunderstandings of regulatory expectations. Practical guidance is offered across all phases of design and development, including methods for performing retrospective gap analyses of design history files to support compliant EU MDR/IVDR technical documentation. The curriculum emphasizes ISO 14971:2019 obligations for establishing, documenting, and maintaining a risk management process throughout the device lifecycle. An optional two‑hour ISO 14971:2019 eLearning module is included for completion prior to the live course. The program is highly interactive, with practical instruction, case studies, and a competency assessment.

Tutors

Course tutors selected from the following:

Janet Book Janet Book brings 35 years of quality experience across industries including medical devices, pharmaceuticals, chemicals, food processing, and consulting. She has performed internal and supplier audits, due‑diligence assessments, and capability evaluations. Her background includes developing quality procedures, audit programs, and quality management systems, along with delivering extensive training. She is a Six Sigma Black Belt, former Carnegie Mellon adjunct professor, and holds multiple ASQ certifications including CQA, CQE, CMQ/OE, and Lead Auditor.

Sarah Moore Sarah Moore has more than 20 years of experience in quality management systems, regulatory compliance (U.S. FDA, Health Canada, EU MDD/IVDD, EPA, China NMPA), continuous improvement, product submissions, recalls, remediation, risk management, and process management. She has worked with both large and small global organizations and emphasizes relationship‑building as the foundation for strong business outcomes.

Jacob Foster Jacob Foster is a Life Sciences advisor with 25+ years of experience in manufacturing operations, quality, and compliance. He has held roles in pharmaceutical and medical device organizations as both an employee and consultant. He holds a B.S. in Chemistry, an MBA (Six Sigma), and is an IRCA‑certified Lead Auditor. His expertise includes QMS effectiveness, global QMS design and remediation, design and development with associated risk management, validation, compliance remediation, and tactical planning.