Medical Device Software Validation

 Configuration management for medical device is a system engineering process for establishing consistency of a product’s attributes throughout its life. Configuration management for medical device is a system engineering process for establishing and maintaining consistency of a product’s performance, functional and physical attributes with its requirements, design, and operational information throughout its lifecycle. The configuration management process facilitates orderly management of product information and changes for purposes as to revise capability, improve performance, reliability, or maintainability, extend life, reduce cost, reduce risk and liability or correct defects. Configuration Management for medical device must include – ·          Enterprise or Unified Supply Chain Configuration Solution ·          Error-Proofing ·          Intuitive and Flexibl...

 Post-sale of medical devices, it is critical to monitor how efficiently the device is working, its downtime, any faulty findings, any risk it poses to the users, end-users etc. In short, continuous monitoring of the medical device must be conducted to check its safety and performance. Any statistically significant increase in serious incidents (severity of risks) as per the trending report leads to appropriate control measures taken like the Corrective and Preventive Actions (CAPA) or the Field Safety Corrective Actions (FSCA) for any Field Safety Notice (FSN) generated. PMS activities must be performed as per Article 83 to Article 89 including data gathering, PMS Plan, PMS/PSUR report, vigilance reporting, trend reporting, FSN and FSCA. Post-Market Surveillance (PMS) & PSUR PMS under EUMDR  Stringent implementation & monitored by PRRC Included in the technical documentation Report to Notified Bodies & Competent Authorities The PMS system will cons...

  Risk is common word in human definition and even child learns the word risk from very age when he starts learning and start doing some adventure of childhood Everybody knows the word risk as common word vocabulary it has lot of importance in medical device field. Though various documents are available, and experts have devised various methods to assess the same. Though we learnt risk based on our perception like we consider certain act as very risky and scared to do the same, stunt man who has practiced that act, does it so easily and risk in his or her perception for that act is very low. This type of perception cannot work in regulated world where we define risk based on assessment as defined in various well accepted standard documents. Let us understand this Medical devices, those have helped improv the standard of life for thousands and thousands of individuals. All those are associated with some sort of risk but are still released based on assessed risk. That risk is...

 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 ...

 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...