This webinar will introduce the topic of Intelligent Design Control for use in Medical Device development with our solution Polarion ALM. To improve the maturity of your design control process, our proposal is to use a structured software-based system to enforce compliant data models and electronic workflows on all elements of the design control in order to assure accuracy of the design information and compliance with regulatory standards. In this way we will improve productivity, speed, and quality of the product development processes, leading to faster time to regulatory submission, approvals, and marketing/commercialization of new and changed devices.
Companies today rely on document management systems implemented in the last decade to piece together the evolution of their product innovation programs. They recognize that the need to refer back to their design controls is becoming more frequent and necessary as adverse events, recalls, and regulatory audits increase.
In addition, longer and more complex product timelines can face unexpected staffing changes, which can require new employees to review the design history to ensure project integrity.
After attending this webinar, you will have a clear understanding what is possible in today’s Medical Device R&D, including:
Product Account Development Specialist for ALM in Med-Tech & Pharma
Presales Solutions Consultant for Polarion