Quality System Regulation Training: 21 CFR 820 and ISO 13485. Contractor is to provide a total of 1 session of the above course in a fully virtual and/or in-person format for four days for up to 50 adult learners.

FDA needs a commercial contractor to provide a total of 1-2 sessions of the above course in a fully virtual or in-person format for four days for up to 50 adult learners to support their learning and development needs. This scope consists of four (4) functional task areas, including, but not limited to:

1. Training Requirements

2. Training Instructor Qualifications and Expectations

3. Training Facilities

4. Class Materials

In performance of the tasks defined in this SOW, the Contractor shall leverage:

• Prior experience delivering quality management system training to FDA staff and industry

professionals

• Standing as a Standards Developing Organization (SDO) developing and maintaining International Standards Organization (ISO) standards

• Contractor training covering ISO 13485: Medical devices – Quality management systems –

Requirements for regulatory purposes as well as training covering other related medical device standards

• A track record of success working with FDA to deliver training that incorporates FDA’s perspectives and expectations

• The Contractor shall also leverage subject matter experts from leading device manufacturers, the FDA, industry consultants, and the standards community, the Contractor’s existing training programs that cover relevant topics, and related standards and documentation, such as “AAMI TIR102:2019, U.S. FDA 21 CFR Mapping to The Applicable Regulatory Requirement References in ISO 13485:2016 Quality Management Systems.”