Author Archives: Sam Lazzara

EO Batch Release Your Way to Full Validation

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”

Quality Policy and Objectives

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 Quality System Process Risk Management

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”