Going From Manual to Automated Development Processes
Three Steps to an FDA and ISO Compliant Implementation
Has your company considered moving to a more efficient electronic product development process to manage BOMs, ECOs, Documents and Quality data but hesitated because of concerns about meeting compliance or weren’t quite sure where to begin or what to do?
Attend this webinar to learn from a medical device client, Autonomic Technologies, Inc. (ATI), a medical device company focused on developing innovative therapies for the treatment of severe headache, on why and how they transitioned from a paper-based system to an electronic Product Lifecycle Management (PLM) system.
Guest speaker, Joseph Ko, Director of Quality for ATI will share best practices and the three steps they took to achieve an FDA and ISO compliant implementation.
Topics covered include:
- Paper-based development process pitfalls
- Why ATI chose to automate
- Why ATI chose PLM
- Things to be aware of as a medical device manufacturer
- Three steps to a compliant implementation (prototype phase, validation phase and migration phase)
- Keys to a successful implementation
This webinar will provide an overview of the timeline and resources needed for ATI’s implementation as well as an overview of the entire validation project including: planning, risk management, FDA Part 11 compliance, requirements, and verification protocols.
Thursday the 22nd of September 2016
19:00 - 19:45 hr
Welcome to The Evertiq Conference, TEC Lund, which will take place on Scandic Star Hotel on September 29 2016! Join your colleagues at this premier industry event – featuring discussions and exhibits on advanced and emerging technologies in printed circuit board design, the current component situation, as well as the latest innovations within electronics assembly technologies.Design Automation @ Embedded Systems
This year the program and the knowledge market focuses on specific themes: "FPGA, Security, Embedded, Internet of Things and PCB Technologies". To make the development process smoother the participating companies will inform you of the improvements implemented in hardware, software and testing within the themes.