Medical Device Software Validation

 IEC 62304 is an essential standard if you are working with the development of medical device software. In this article, you will get an overview of the scope of this standard, along with the configuration management process which will help you keep track of information, changes, and source code. IEC 62304 is a process standard with a list of requirements and activities you should carry out throughout your development cycle. There are no requirements in the standard forcing you to apply a specific development method. You can use whatever method you want if you acknowledge the process approach and perform the required activities in the standard. Some key elements in the standard are development, risk management, configuration management , problem resolution, and maintenance. Each of the processes is divided into activities where the development process has the most activities. A software project usually has more configurations items to control then all documents together in a ...

 It is the process to generate clinical evidence to establish the safety and efficacy applicable to all the classes of medical devices. The Clinical Evaluation should be drafted with the help of MEDDEV 2.7/1 Rev. 4, using MDCG Guidelines (MDCG 2020-1, MDCG 2020-6, MDCG 2020-13, IMDRF MDCE WG/N56FINAL:2019 and Annex XIV, Article 61 of EU MDR) The legal manufacturer must draft the Clinical Evaluation Report (CER) in compliance with General Safety and Performance Requirements (GSPR) Checklist. The aim of a CER is to reduce the risk that the users and patients are exposed to when using a medical device. The final Clinical Evaluation Report (CER) will summaries: 1.        Device description and intended use of the product. The purpose of CER is to collect, appraise and analyze the clinical data obtained from literature searches for the safety and effective performance of the device. 2.        The text articles obtained...

 It is a requirement that all manufacturers must follow those requirements through establishing proper system within organization so that all devices produced are safe to use. Just to give you an example. To ensure the standard of medical devices, the FDA (Food and Drug Administration) has laid down design control regulations for medical device manufacturers by incorporating them into the standard System Regulation, 21 CFR Part 820. These design controls are established to take care of the specified regulations and therefore the quality aspects of medical devices, like safety, performance, also as product dependability associated with software, hardware, services, or processed materials during the design and development phase. Efficiency in the process comes only if concurrent engineering practices are put into place meaning involvement of Design people with engineering, manufacturing, and quality in each phase, so if correction is needed it is addressed there and then and not...

  Manufacturers are expected to follow the quality system requirements described in FDA 21 CFR part 820This document guides to govern the design, manufacture, packaging, labelling, storage, installation, and servicing of medical devices intended for human use. The requirements in 21 CFR Part 820 are meant to ensure the safety and efficacy of medical devices sold in the US marketplace. FDA conducts regular inspections of medical device manufacturers to ensure compliance with these regulations. The inspection process, known as the Quality System Inspection Technique (QSIT), evaluates a company’s internal quality processes to determine whether they are in alignment with or in violation of these regulatory requirements. If any violations are discovered, the inspecting agent from FDA will issue in the form of 483 Inspectional Observations, Warning Letters what is applicable   Here are the most common mistakes companies run into with FDA 21 CFR Part 820: 1.  C...

  What is An FDA Form 483?   A Form 483 is a form through which FDA inspector reports and communicates the results of his audit findings to a head of facility. This is a regulatory form, and all findings are bound to auditee and they need to be closed through corrective and preventive action.The observations are usually mentioned in descending order of importance. Some time they are referred with picture of spot or shown to a witness touring with auditor or document is attached to site some observation or noncompliance. Organisation needs to understand before auditor leaves. ·          Gain an understanding of observations noted and assure their accuracy ·          Understand the broader message the agency is sending ·          Identify and discuss any errors in observations ·          Ask questions · ...