Introduction to ISO 13485:2016 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.
Day 1
General requirements
Control of documents
Control of records
Validation of computer software
Management responsibility
Resource management
Design and development
Day 2
Production and service provision
Measuring and monitoring equipment
Control of nonconforming products
Complaint handling
Reporting to regulatory authorities
Internal audit
Corrective and preventive action
Any person(s) involved in one or more stages of the medical device lifecycle starting from the design & development phase through production and post-production phase. Typical job functions include but not limited to:
Quality Management System
Quality Assurance
Quality Engineers
Manufacturing Engineers
Regulatory Compliance
Available Workshops:
Please contact AQS Labs.
Workshop Fee:
S$500 - Please contact AQS Labs for group rates.