ISO 13485:2016 has a broader view of risk management than in the past. … ISO 13485:2016 QMS Process Risk Management
Now is the time to get the 13485 monkey off your back.
Did you notice that the published regulation does not have a table of contents or bookmarks? … Europe Medical Devices Regulation (MDR) 2017/745 with Table of Contents and Bookmarks
Does your organization’s Quality Policy inspire you, or tire you?
Are you Quality Objectives follow a framework established by the Policy statement? … Quality Policy and Objectives
Still trying to figure out what to do about EN ISO 14971:2012? … EN ISO 14971:2012 Impact Assessment
Before you read the vocabulary definitions in ISO 9000:2015 you need to know what the “small words” mean. … Words Matter – ISO 9000:2015 QMS Vocabulary
Accelerated Aging is utilized to establish the shelf life of a product relatively quickly. … ASTM F1980 Accelerated Aging Calculator