Medical Device Software Validation

Software Verification and Validation (Software V&V) is an integral part of software design that spans all the development stages as specified in IEC 62304 which addresses the Software Development Life Cycle (SDLC) of medical software and software embedded within medical devices. Software Verification is to test if the software was designed as per requirements and Software Validation is to test if the right product was built for the user.Medical device software validation generally occurs during or at the end of the development cycle.  The difference between Software Validation & Software Verification can be answered by asking these mentioned questions: ·          Verification: Are we building the product, right? ·          Validation: Are we building the right product? Software validation is a process of checking if the product will meet the customer’s actual needs, while verification ...

  Why is the modification in the regulation ( MDD to MDR Transition) adapted? History : You may be aware of the breast implant scandal in France wherein instead of medical grade Silicon, a low-quality Silicon was used as a raw material for breast implants which got ruptured and there were several complaints filed which led to the recall of the device by the manufacturer. Because of these kinds of incidents, the MODIFICATION to MDD came into the picture and it’s called MDR, which is more comprehensive and detailed than MDD. MDD Vs EU MDR Context MDD EU MDR Articles 23 123 Annexes 12 17 Rules 18 22   ·          How do we adapt to MDR? ·          Gap analysis while considering additional requirements of MDR. ·          Re...

  Risk, risk assessment, estimation, evaluation, risk control, and risk management are very well defined in BS EN ISO 14971: 2019. This standard is used for medical devices, IVDR, and has become a harmonized standard for risk management in Canada. Risk management is defined as the “ Systematic application of management policies, procedures, and practices to the tasks of analyzing, evaluating, controlling, and monitoring risks .” What are the steps in the risk management process? ·          Identify Hazards, Hazardous Situations in Production and Postproduction, Literature Reviews, Adverse Event Databases ·          Estimate and Evaluate the Related Risks ·          Apply Control Measures for Risks ·          Effectiveness Check ·          Residual Risks Acceptability Check...

 Mergers & Acquisition in the healthcare industry has been strong in recent years and is expected to grow. Acquiring a new company or product line can have a positive business impact, but it also comes with implementation, process, quality & regulatory challenges. Especially, in the medical device industry, failure to comply with regulations can result in the loss of authority to deliver products and services. Post-Merger Integration Issues ·          Maintaining Momentum ·          Employee Engagement ·          Senior Management Issues ·          The Culture Shift ·          Technology Integration ·          Synergy Implementation ·          Customer Engagement ·      ...

  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. What ISO 14971 is important? ISO 14971 helps your company establish, document, and maintain a systematic process to manage the risks associated with the use of a medical device. This includes ongoing monitoring of field experience, thereby embracing the concepts of continuous improvement and state-of-the-art device performance. To maximize the effectiveness of your risk management system, ISO 14971 can and should be an integral part of your quality management system (QMS) as required by ISO 13485. Steps Involved in Risk Management for Medical Devices ·          Risk Management Framework & Planning ·  ...

 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...