Design control is a global regulatory requirement that must be fulfilled before any device premarket applications (US PMA, 510(k), CE Mark, etc) are submitted. Participants will learn “how-to” construct design plans, design input requirements, design verification test protocols/reports including the use of risk-based sample size determination and statistical techniques, and discuss the importance of other relevant verification & validation activities (e.g. biocompatibility, usability, aging, sterilization, process validations), device master record, design history file, design reviews, and design changes. Participants will also learn common mistakes, pitfalls, relationship with other quality system processes and consequences when design control is not properly performed.

Risk analysis is an integral part of the design control process. Participants will learn “how-to” construct, evaluate, estimate, and control risks from a device design (dFMEA) and application (aFMEA) perspective using actual marketed medical device products. Participants will also learn common mistakes, pitfalls, relationship between design, usability, and production of device, relationship with other quality system processes and consequences when risk analysis is not properly performed.

Equipment qualifications & physical test method validations are prerequisites of process validations and are regulatory requirements. Participants will learn “how-to” prepare and write test protocols/reports (IQ/OQ, GRR studies), operate and qualify actual equipment used in production and testing, use statistical software (Minitab®) for data analysis, and good documentation practices. Participants will also learn about regulatory requirements, common mistakes, pitfalls, and consequences when equipment and test methods are not properly validated before use.

Process validation is an integral part of design control process, contract manufacturing and are regulatory requirements. Participants will learn “how-to” design/prepare for process validation studies, write validation test protocols/reports including the use of risk-based sample size determination for simulated processes, use of statistical software (Minitab®) for analysis and interpretation of data, handling of unanticipated deviations, and good documentation practices. Participants will also learn common mistakes, pitfalls, and consequences when a production process is not properly validated before use.