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 [...]
The Quality System Regulation 21 CFR 820 and ANSI/AAMI/ISO 13485 Navigating Regulatory Requirements
The regulatory world for quality management systems (QMS) is changing fast. To succeed in today's global market, the manufacturers of medical devices must understand those requirements. This intensive 4 ½ day course provides quality system [...]