TDS PDF

Quality Management System (QMS) Recommendations on the Application of the U.S. FDA’s CGMP Final Rule on Combination Products Original standard AAMI TIR48-2015 in PDF full version. Additional info + preview on request

Document status: Replaced by St AAMI TIR48-2024

Quality Management System (QMS) Recommendations on the Application of the U.S. FDA’s CGMP Final Rule on Combination Products Original standard AAMI TIR48-2015 (2021) in PDF full version. Additional info + preview on request

Document status: Replaced by St AAMI TIR48-2024

Quality management systems (QMS) recommendations on application of the U.S. FDA’s CGMP final rule on combination products Original standard AAMI TIR48-2024 in PDF full version. Additional info + preview on request

Document status: Active

Design of training and instructional materials for medical devices used in non-clinical environments Original standard AAMI TIR49-2013 in PDF full version. Additional info + preview on request

Document status: Replaced by St AAMI TIR49-2013 (2020)

Design of training and instructional materials for medical devices used in non-clinical environments Original standard AAMI TIR49-2013 (2020) in PDF full version. Additional info + preview on request

Document status: Active

Post-market surveillance of use error management Original standard AAMI TIR50-2014 (2017) in PDF full version. Additional info + preview on request

Document status: Replaced by St AAMI TIR50-2014 (2025)