Sam Lazzara's Medical Device Quality Central Blog

Sam Lazzara Resume LinkedIn Profile   Documents Services Schedule Call   +1 510 397 9739 sam@lazzara.net Medical device package validation is typically addressed separately from sterile barrier heat seal process validation. My preference is to perform a single comprehensive study that meets requirements for heat sealer process validation (per ISO 11607-2:2006) and packaging validation (per ISO 11607-1:2006). A single combined study can be more economical than performing separate studies.   The combined study includes Installation Qualification (IQ), Operational Qualification (OQ) (high and low runs), and 3 Performance Qualification (PQ) runs. All test articles (dummy packages) are exposed to the worst-case routine sterilization process, climatic conditioning  and distribution simulation (per ASTM D4169 for example), and accelerated and real time aging (per ASTM F1980). Actual working devices need not be enclosed in the packaging, but a dummy device that m...

Sam Lazzara Resume LinkedIn Profile   Documents Services Schedule Call   +1 510 397 9739 sam@lazzara.net ISO 13485 requires the control of "documents of external origin" such as regulations, standards and guidelines that impact the quality management system (QMS). Changes to these external documents must be identified and appropriate actions taken to maintain "state of the art" medical devices. For example, Essential Requirement 2 of the European Medical Device Directive states: "The solutions adopted by the manufacturer for the design and construction of the devices must conform to safety principles, taking account of the generally acknowledged state of the art." Keeping up to date with evolving international regulations, standards and guidelines is always a challenge. It is one thing to become aware of revised documents; it is something else to determine the impact of the revisions on your QMS and devices. Regulations, Standards, Guidan...