Medical Device Software Validation

 Medical device manufacturers receive observations (Form 483 Compliance) 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. Companies require substantial number of unplanned resources, budgets & at the worst are declined an opportunity to sell, shutting down facilities and even prosecution of responsible individuals until the observations are cleared. Companies may also undertake product remediation to resolve issues that they are aware of in their product design and development process. The 6 biggest ways an experienced compliance and remediation consulting firm can help those recovering from a Warning Letter (Form 483 Compliance) or FDA Warning Letter ·          Objective, un-biased perspectives  ·          A com...

 The EU MDR has significantly impacted the way medical devices are regulated in Europe. As part of regulatory compliance, medical device manufacturers need to create and maintain a Clinical Evaluation Report (CER), a document essential for CE Marking. Here are expert tips on what to consider defining a robust CER strategy.   Clinical Evaluation Report (CER) makes a strong case for your device and its intended use backed by impactful scientific evidence. The aim of a CER is to reduce the risk that the users and patients are exposed to when using a medical device. Following are some steps to follow -   1.        Define a CER protocol and strategy   2.        Demonstrate equivalence   3.        Evaluate literature review data   4.        Determine requirement for clinical investigation   5.        Monit...

 Clinical Evaluation Report (CER) makes a strong case for your device and its intended use backed by impactful scientific evidence. The aim of a CER is to reduce the risk that the users and patients are exposed to when using a medical device. Clinical evaluation is an essential prerequisite for risk management. It justifies the assumptions made in the risk management file, with respect to the benefits and thus the acceptance of a certain risk-benefit ratio. When looking at the clinical evaluation of a new device, the available data will typically be limited. The evaluation will be based on the best available data at the time; however, the best indication of safety and performance will only be obtained once the device is in use. With the increasing lifespan of devices on the market, there will be increased need for clarity regarding the risk/benefit profile of the device. IZiel completes the Clinical Evaluation Report (CER) as per the following changes in revision Med-Dev Rev. ...

  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. IZiel works with your team to assist you to complete all the following Process Validation for Medical Devicesactivities Process Validation Master Plan (PVMP) Define the manufacturing process flow. For each process step, define the process requirements. Process Characterization Process Characterization is the science of understanding the effects of inputs and other uncontrollable variables on the desired outputs or requirements of a process using robust and proven statistical methodologies. Process Characterization is the first step of the Operational Qualification (OQ) activity. Equipment Installation and Qualification (IQ) IQ is the task of proving that the eq...

 As the US Food and Drug Administration’s medical device and IVD review process becomes more complicated, partnering with an experienced USFDA Regulatory Consultants can make a significant difference in your authorization and compliance efforts& process. If your goal is to implement a quality management system that complies with the FDA Quality System Regulation (QSR) or obtain 510(k) premarket clearance, skilled USFDA Regulatory Consultants can guide you through all US regulatory requirements. Medical Device Manufacturers require USFDA Approvals to sell their products in USA. USFDA differentiates product approvals in Class I, II &III depending upon the risk associated. The submissions include self-certification, 510(k) and PMA depending upon the class of the product. IZiel implements an Outcome-Based Delivery Model to provide complete solution from developing engineering documentation to receiving USFDA Approvals & establishment registrations there...