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 a familiar presence in the lab. The benefits of synthetic bioengineering with CRISPR CRISPR-Cas9, the full name for the editing [...]
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. This two and a half day course goes beyond small-team and software-only applications and demonstrates how Agile practices can be [...]
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 shared learning experience. Examples of design control tools, templates, and practices, in use by AAMI member companies, stimulate discussion and [...]
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 entire course, attendees have the unique opportunity to participate in a shared learning experience. For more info: http://www.aami.org/events/eventdetail.aspx?ItemNumber=5822
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 professionals with the information needed to develop and maintain a quality system program that conforms with the FDA's Quality System [...]
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 are key to global market access and regulatory compliance. For more info: http://www.aami.org/events/eventdetail.aspx?ItemNumber=5759
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 professionals with the information needed to develop and maintain a quality system program that conforms with the FDA's Quality System [...]
This 2 day course provides intensive coverage of the elements of a corrective and preventive action (CAPA) system. Some primary topics include: the purpose of a CAPA system and how it is integrated throughout a Quality Management System; appropriate data sources and how to coordinate, analyze and manage them; methods for verifying and / or [...]
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 shared learning experience. Examples of design control tools, templates, and practices, in use by AAMI member companies, stimulate discussion and [...]
This annual celebration is designed to promote the awareness of—and appreciation for—the critical work of biomedical equipment technicians (BMETs), clinical engineers, and other members of the healthcare technology management (HTM) field. For more info: http://www.aami.org/events/content.aspx?itemnumber=1236&navItemNumber=566