Medical Device Software Validation

 The U.S. Food and Drug Administration (FDA) is authorized to perform random inspections and audits, and these inspections can lead to FDA warning letters and FDA Form 483 observations.  Medical device manufacturers receive observations ( Form 483 ) and / or warning letters on completion of USFDA Audit. The document outlines any violations of Good Manufacturing Practices (GMP’s) such as the facility, equipment, processes, controls, products, employee practices or records. Some tips to avoid a warning letter and form 483 observation – ·          Be Inspection Ready ·          Clearly Written Standard Operating Procedures ·          Proper Document Control ·          Develop a Compliance Culture ·          Correct Observations in Real-time ·      ...

  Configuration management is “a process for establishing and maintaining the consistency of a product’s performance, functional and physical attributes with its requirements, design and operational information throughout its life.” It is imperative to develop product configurations and manage them effectively. A structured configuration management program ensures accurate and consistent product documentation (e.g., requirements, design, test, and acceptance documentation) along with the actual physical design of the product. Configuration Management plays an important role to ensure thorough product variations to enhance customer satisfaction, competitiveness, profitability & continuous changes/requirements. Therefore, it’s critical that the product and process configuration is unified across the organization, which minimizes handoffs of specialised information. Configuration Management must include – 1.            Ent...

  “When do I need a Quality Management System (QMS)?” is the most common question that we get from new clients who are just entering the medical device field. The answer depends on your target market and your exit plan. QMS is a quality management system as the name suggests this is essential for any simplest medical device too. There are two aspects of QMS. One initial is to build a system wherein you will document the system mostly as per ISO standard 13485. System build means, writing down the procedure for each section of ISO stating what, how, when and where you are going to do. At this stage, you are only developing a strategy or system but not doing anything in action. In the second stage, you will carry out the action and create evidence of action through records of your system. This is an explanation ofwhat QMS one must do. This is just a basic need. Then comes regulatory requirements which are different for different countries. These are must requirements, and you...

  Process validation is a formal methodology that allows companies to manufacture products on approved and qualified equipment, with a defined process leading to products that consistently meet their predetermined specifications and quality requirements. Process Validation for medical devices is conducted to ensure consistent delivery of quality products meeting its predetermined specifications/requirements and quality characteristics. This enables to ensure the complete safety & efficacy of medical device. Pharma Vs. Medical Device Process Validations, Points to be considered as bellow. 1.        Qualification Strategy 2.        Timing of Critical Parameters 3.        Measurement Method 4.        Process 5.        Equipment 6.        Batch Production 7.        Process ...

 Medical devices have caused so many patient deaths and over a million injuries in the past decade. A qualified medical device risk management consultant can help you resolve safety issues and, ideally, remove your anxiety that your products could harm the end user. 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. IZiel’s Expertise IZiel Healthcare has the expertise to write risk management procedures as per ISO 14971 and then create or restructure the risk management file as per the established procedures. IZiel Healthcare has broad experience creating risk management files from simple (Class I) to complex (Class III) medical devices. Our team uses the following tools to identify the risk associated wit...