Risk Management and Design Controls for Medical Devices and IVDs

This instructor-led, three-day course covers design control principles relative to the U.S. 21 CFR Part 820, ISO 13485:2016, the EU MDR, and EU IVDR utilizing key foundations of the risk management process defined in ISO 14971:2019.

This course provides comprehensive coverage of the essential requirements for medical device design controls, enabling learners to engage in structured discussions that clarify common misinterpretations of regulatory expectations and the resulting impact on design control effectiveness. It presents practical guidance across all phases of device design and development, including methods for conducting retrospective gap analyses of design history files to support the development of compliant technical documentation under the EU MDR and EU IVDR. 

The curriculum integrates the principles of ISO 14971:2019, outlining the obligations for manufacturers to establish, document, and maintain a rigorous risk management process that identifies hazards, evaluates and controls associated risks, and continually verifies the effectiveness of implemented controls—an ongoing set of activities essential throughout the device lifecycle and fundamental to a robust quality management system. 

This course also includes an optional, self-paced two-hour ISO 14971:2019 overview eLearning module that should be completed prior to the start of the live instruction. Through sharing of current design and development processes, this course is highly interactive and includes practical instruction, case study exercises, and a competency assessment.

At the end of this training, learners will be able to:

• Identify key regulatory requirements for design controls and risk management
  • European Union Regulations
  • Quality System Regulation
  • ISO 13485:2016
• Identify key principles of ISO 14971:2019
• Recognize potential exemptions from design control requirements
• Identify when, during a design and development project, design control requirements apply
• Conceptualize a design control process graphically
• Identify how risk management affects quality management system practices
• Recognize one method for the practical application of risk management principles

This class is vital for both regulatory affairs and quality assurance professionals involved in developing and manufacturing medical devices. This course provides critical knowledge for those looking to expand their knowledge of comprehensive design and risk management processes and their interactions with the entire lifecycle of a medical device from conception to decommissioning and disposal.

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.