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 [...]
International Conference on Medical Device Standards – June 19-20, 2018 in London, UK
The AAMI/BSI International Conference on Medical Device Standards and Regulations is coming to Europe! During this event, government and industry leaders from Europe and the US will explore developments in international standards and regulations that [...]
The Quality System Regulation 21 CFR 820 and ANSI/AAMI/ISO 13485: Navigating Regulatory Requirements, June 18-22, 2018 in Arlington, VA
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 [...]