Workshops

Design control is a global regulatory requirement that must be fulfilled before any device premarket applications (e.g. US, EU, Singapore, etc) can be 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.

ISO 13485 is an internationally recognized quality management system (QMS) standard for any organizations involved in one or more stages of a medical device lifecycle, starting at design and development through production, storage and distribution and continues to installation, servicing, final decommissioning and disposal of a medical device. Legal and contract manufacturers are required to establish and maintain QMS processes to help ensure that their products and/or services will consistently meet customer and regulatory requirements. This training workshop provides learners with awareness of each requirement and its application including examples of common industry mistakes.

Risk analysis is an integral part of the design control and risk management 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 and usability of devices, relationship with other quality system processes and consequences when risk analysis is not properly performed or untimely.

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.