Join colleagues from your local regulatory community for a new and innovative way to learn about quality management systems from a subject matter expert and one another. The RAPS Twin Cities Chapter is recording a presentation on Design Controls, which can be accessed at your convenience, and hosting an online “Ask the Expert” session with the presenter. Can’t make the live session? No problem, the entire discussion will be archived for you to access later. (Check out the “How Does It Work?” tab below for a detailed description.)
All medical device manufacturers supplying medical devices to the US are required to maintain a quality management system in compliance with Part 820 the Code of Federal Regulations (CFR) Title 21 (21 CFR 820). Quality management system requirements cover a broad range of areas, including production and process controls, corrective and preventive actions, product development and management.
The ISO 13485 standard is an effective solution to meet a quality management system’s comprehensive requirements. Adopting ISO 13485 provides a practical foundation for manufacturers to address the EU medical device directives, regulations and responsibilities and demonstrate a commitment to medical devices’ safety and quality.
This webcast is based on the 21 CFR 820 Quality System Regulation and ISO 13485 Medical devices—Quality management systems—Requirements for regulatory purposes and will explore the design control elements of design inputs, design outputs and design verification.
After viewing the recorded presentation, attendees will understand:
- Design input requirement categories and qualities
- The relationship between design input requirements, design output and design verification
- Design verification basics
- Tools and techniques to support new product development
This activity is coordinated by the RAPS Twin Cities Chapter and is intended to encourage knowledge sharing and community development. RAC holders may claim one RAC recertification credit.