Sam Lazzara's Medical Device Quality Central Blog

Sam Lazzara Resume LinkedIn Profile   Documents Services Schedule Call   +1 510 397 9739 sam@lazzara.net There are calculators for figuring out how fast you can pay off your mortgage, so why not have a calculator to figure out how fast you can age your medical devices? ASTM F1980 is the standard most people refer to for medical device accelerated aging. Its title is Accelerated Aging of Sterile Medical Devices. I am sharing my Excel Accelerated Aging Calculators workbook . It is not formally validated but I am pretty sure it is accurate. Please let me know if you find any mistakes or have improvement suggestions. CAUTION - There are three different tabs in the Excel workbook based on different assumptions for the ambient temperature. I have tabs for 20, 22 and 23 deg C. The standard mentions using 25 deg C as a conservative number but it does not "require" this temperature to be assumed. If you are feeling frisky, do what I do lately and use/justif...

Sam Lazzara Resume LinkedIn Profile   Documents Services Schedule Call   +1 510 397 9739 sam@lazzara.net I can think of 3 options when an engineering specification (design verification spec) is not met. 1. Change the specification based on a technical justification and comparison to design validation results if available (actual clinical use is the best design validation if it is applicable to the design that failed verification testing). No retesting is required - if it meets the intended use and user needs that is a great justification for "loosening" the engineering specification. Note - For this approach it is important to look at how the engineering spec was originally derived. The original logic must have been flawed. 2. Find fault with the test method (either human-error or equipment deviations from the approved method or other problems encountered with the method as written). Retesting using the correct test method is required. 3. Implemen...

Sam Lazzara Resume LinkedIn Profile   Documents Services Schedule Call   +1 510 397 9739 sam@lazzara.net Companies developing a new device are often interested to determine the European Notified Body (NB) associated with similar "competitive" devices. Unfortunately, to my knowledge there is no central European database that can be searched for this information. Here are some ideas for how to go about this. Product Labeling Device labels and instructions for use carry the CE marking if they are associated with devices commercially distributed to Europe. All device classes except "Class I non-sterile non-measuring function" require NB review of the Technical File and also require the 4-digit NB number to be shown adjacent to the CE marking in product labeling. Once you know the NB number, go here to determine the NB name: Notified Bodies for Medical Device Directive (MDD) Notified Bodies for Active Implantable Medical Device Directive (AIMDD...