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”
Link to Sam Lazzara’s EN ISO 14971:2012 Flow Chart Still trying to figure out what to do about EN ISO 14971:2012? The ASQ Biomedical Division just published an article I wrote called Risky Business – Demystifying EN ISO 14971:2012. To view the article, go here. EN ISO 14971:2012 became a European harmonized standard on AugustContinue reading “EN ISO 14971:2012 Impact Assessment”