Medical Device Software Validation

 As we all know, some USFDA regulations are extremely specific and special for medical devices and IVD which are supposed to be sold in the USA.   So even for Global manufacturers, approval in many countries and selling them would not just automatically give approval for sale in the USA.   Recommending US FDA consulting to medical device and IVD manufacturers may look sales gimmick so let us first look what are the requirement and corresponding regulations or documentation. 510K submission, IDE (investigation device exemption) submission or clinical trials, for Classification query and resolution, if the manufacturer is outside then effective representation, Audits, and audits of suppliers, form 483, and warning letter resolution, apart from other general guidance on day-to-day affairs like pre-submission meeting, 21 CFR part 820 understanding. IZiel adopts an analytical mindset thus enabling us to root out all possible non-conformances in a regulatory submission. ...

  Risk management is an important part of the medical device product development lifecycle. It helps medical device manufacturers to ensure that the final product is reliable, works as expected, and causes no harm. The main purpose of the risk management process is to reduce or mitigate the chances of failure in the product. The one most people are familiar with is risk analysis associated with the design of a medical device. The following are 4 Types of Risk Analysis – 1.        Design Risk Analysis - Risk analysis is the first type of risk analysis we are reviewing in this article. The most common types of design risk analysis are the design failure modes and effects analysis (dFMEA) and the fault-tree analysis (FTA).The dFMEA is typically preferred by engineers on a development team because they designed each of the components. However, during a complaint investigation, the FTA is preferred. Therefore, the dFMEA or the FTA will need to be rev...

  Design Control is an important part of the medical device design & development. To control the design and development of a medical device, regulations have been developed by regulatory bodies such as  USFDA , European Commission and others. These regulations are known as “Design Control.” Following are the steps Smooth Design Transfer Process ·          Plan Early ·          Follow Requirements ·          Take Time ·          Select a Manufacturer ·          Document as You Go Design control is a set of procedures and practices applied to the design activity intended to ensure that the output product meets the input requirements. It includes understanding user needs, and requirements and thereafter designinga medical device to meet those requirements alongwith risk an...