The Annex I “Essential Requirements” of the European medical device directives have been supercharged and reincarnated
ISO 13485:2016 has a broader view of risk management than in the past.
Did you notice that the published regulation does not have a table of contents or bookmarks?
I have had several early-stage device company clients who are interested to get to “First In Man” (FIM) clinical use without breaking the bank. My job is to save the client enough money so they can pay my fee and have money left over for other things (like a great Christmas Party). If device sterilizationContinue reading “EO Batch Release Your Way to Full Validation”
Does your organization’s Quality Policy inspire you, or tire you? First, let’s review US FDA and ISO 13485 requirements and ISO 14969 guidance. After that, I am sharing my current “state of the art” model for a Quality Policy and corresponding Quality Objectives. Quality Policy Definitions ISO 9000:2005 – Overall intentions and direction of anContinue reading “Quality Policy and Objectives”
ISO 13485:2016 has a broader view of risk management than in the past. Risks are to be considered in terms of the impact on medical device safety and performance, and in terms of meeting regulatory requirements. For managing quality system process risks, rather than adding a “Risk” section to each Standard Operating Procedure (SOP) as some haveContinue reading “ISO 13485:2016 Quality System Process Risk Management”
Before you read the vocabulary definitions in ISO 9000:2015 you need to know what the “small words” mean.
Accelerated Aging is utilized to establish the shelf life of a product relatively quickly.
I can think of 3 options when engineering specification (design verification spec) is not met.
Unfortunately, there is currently no centralized database to search Notified Bodies and their Client companies. Here are some ideas for how to go about this.