Reverse Engineering Medical Device Design Outputs

Medical device manufacturers often face challenges with both legacy and new devices in ensuring that design outputs meet regulatory requirements. This interactive course will provide practical solutions for creating robust design outputs using existing information and leveraging the critical thinking of engineers and scientists.

LEARNING OBJECTIVES:

• Understand the concept of design outputs from the perspective of ISO 13485 and 21 CFR Part 820.30.
• Identify situations where design outputs might need remediation.
• Utilize existing information sources, including post-market data, to create robust design outputs.
• Develop a traceability matrix to link design inputs to design outputs.
• Integrate post-market data into the Design History File (DHF) for continuous improvement.

AREAS COVERED:

• What are Design Outputs from the perspective of ISO 13485 and 21CFR Part 820.30
• What are some situations where Design Outputs might need remediation
• What are some of the existing information sources a manufacturer might already have to create robust Design Outputs

WHO SHOULD ATTEND:

• Quality Assurance Departments
• Engineering Departments
• Regulatory Affairs Departments
• Research and Development Departments
• Manufacturing Departments
• Production Departments
• Compliance Departments
• Design Engineers
• Scientists

Course Director: Kate Leith

Kate Leith has over 30 years of experience in the medical device and IVD industries, spanning the entire product lifecycle from design and development to post-market and technical support. For the last 10 years she has provided consulting, training, and audit support to small start-ups and multinational device manufacturers in FDA QSR processes and EU regulations and standards at Oriel STAT A MATRIX and ELIQUENT. Prior to that she worked at Beckman Coulter, Sanofi Diagnostics Pasteur, and small biologics manufacturers. She holds numerous certifications and patents, but her true passion is in helping people and organizations achieve their full potential in Quality and Regulatory matters. Kate holds a MS in Microbiology and Immunology from the University of Louisiana and a MBA from Southern New Hampshire University.