Monthly Archives: August 2018

//August

The Quality System Regulation 21 CFR 820 and ANSI/AAMI/ISO 13485: Navigating Regulatory Requirements, October 1-5, 2018 in Dun Laoghaire, Ireland

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 [...]

2018-08-30T18:31:40+00:00August 30th, 2018|

The Quality System Regulation 21 CFR 820 and ANSI/AAMI/ISO 13485: Navigating Regulatory Requirements – September 24-28, 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 professionals with the information needed to develop and maintain a quality system program that conforms with the FDA's Quality System [...]

2018-08-16T18:06:16+00:00August 16th, 2018|

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 a familiar presence in the lab. The benefits of synthetic bioengineering with CRISPR CRISPR-Cas9, the full name for the editing [...]

2018-08-10T14:26:01+00:00August 10th, 2018|

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. This two and a half day course goes beyond small-team and software-only applications and demonstrates how Agile practices can be [...]

2018-08-03T14:53:36+00:00August 3rd, 2018|