Trainer: Vincent Cheung
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.