Workshops

Design control is a quality management system requirement (EN/ISO 13485, 21 CFR Part 820) that is applicable to all medical devices regardless of their classification. The evidential information generated is used to prepare technical documentation required for regulatory submissions such as CE marking, premarket notification (510k), Premarket Approval (PMA), and ASEAN CSDT product registration. Trainees will learn real-world application of the design control process with the focus on “how-to” bring a medical device through different design and development stages efficiently and effectively. The interrelationship with other applicable regulatory requirements such as risk management (ISO 14971), software development (IEC 62304), biocompatibility (ISO 10993), usability engineering (IEC 62366), and other product safety testing will be discussed. Trainees will also learn the practical methods of establishing and maintaining documentation for design planning, design input requirements, design outputs, sample size determination, test protocols/reports, design verification testing, statistical data analysis, design validation including clinical evaluations, and design change management.

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. All medical device manufacturers are required to implement and maintain applicable QMS processes to help ensure that their products and/or services will consistently meet customer and regulatory requirements. This training workshop provides trainees with awareness of each requirement and its real-world application including examples of common industry mistakes.

The application of risk management to medical devices including software is a global regulatory requirement regardless of device classifications and when implemented effectively, manufacturers will be able to achieve regulatory compliance and effectively manage safety and security risks associated with their medical devices for the patients, clinicians, healthcare professionals, and other persons involved throughout the entire medical device life cycle. Trainees will learn the process of risk management that needs to be applied throughout a medical device life cycle in accordance with EN/ISO 14971:2019 with focus on “how-to” perform risk management planning, risk assessment, risk estimation, risk evaluation, risk control, and the evaluation of the overall residual risk. The collection and review of information in the production and post-production phase will be discussed. Trainees will also learn how to apply different risk analysis methods such as Preliminary Hazard Analysis (PHA), Failure Mode and Effects Analysis (FMEAs), and Software Hazard Analysis (SHA) to generate a comprehensive risk analysis and related documentation that meets regulatory requirements.

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.