Webinar – Newly Released Data Behind FDA’s Historic Clearance of IDx-DR – Wednesday, August 29, 2018 from 12:00 pm to 12:30 pm CDT
The technology known as CRISPR — clustered regularly interspaced short palindromic repeats — has taken the field of synthetic bioengineering by storm. It emerged as a gene-editing tool only five years ago, but has become [...]
Application of Agile of Medical Device Systems – September 19-21, 2018 in Arlington, VA
For many years software development teams have been using Agile Software Development methods, but Agile is not just for software. Agile's Lean Product Development principles also apply to the development of hardware-based products and systems. [...]
Design Control – Integrating The Quality System Regulation and ANSI/AAMI/ISO 13485 Requirements – September 5-7, 2018 in Freising, Germany
This intensive 2½ day course covers the practical application of the design control requirements of the Quality System regulation to medical devices. This course offers FDA and industry the unique opportunity to participate in a [...]
Design Control Requirements – Integrating the Quality System Regulation and ANSI/AAMI/ISO 13485 – August 29-31, 2018 in Arlington, VA
This intensive 3 - day course provides complete coverage of design control requirements for FDA Quality System Regulation, ANSI/AAMI/ISO 13485:2016, and the Medical Device Single Audit Program (MDSAP). With the participation of FDA representatives during [...]