Steps for Getting CE Marking

Process Validation 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 devices. The Three Stages of Process Validation ·          Process Design ·          Process Validation or Process Qualification ·          Continued Process Validation IZiel team makes all efforts to understand the process in detail and investigate the applicable standards and guidelines to determine the process requirements. IZiel’s approach has been very comprehensive and methodical as depicted in the flowchart. IZiel has successfully delivered various projects through the Onshore-Offshore Work Model, completing projects faster and with major cost savings. The IZiel team works together with the client to plan, execute, compile re...

Do you know the importance of complaints? Its legal implications? Impact on Post-Market Surveillance? Complaint Handling plays an important role in the device industry and is a regulatory requirement as well as a risk-reduction imperative. Thus, it is extremely important to manage and resolve complaints per regulatory bodies' guidelines and standards. Medical device companies must establish a customer complaint-handling process to collect feedback on potential adverse events that must be reported to the FDA. IZiel Approach for Detailed Complaint Handling   ·          IZiel would adopt & implement these steps to help you with compliant handling. ·          Establish Complaints Handling System ·          Initial Review and Evaluation ·          Investigation of Failures ·       ...

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. The overall aim of a clinical evaluation is to assess and analyze clinical data regarding the medical device to provide evidence for the product’s clinical safety and performance. Key Steps for Clinical Evaluation Report ·          Identification of regulatory requirements to be supported by clinical data ·          Identification of available clinical data for the device under evaluation and state of the art for the intended use ·          Determination if there is sufficient clinical data for the safety and performance of the device under evaluation ·          If clinical data is not suf...

  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. If you plan to sell your medical devices in Europe, you must produce and maintain a Clinical Evaluation Report (CER) that complies with Medical Devices Regulation (MDR) 2017/745.   Clinical evaluation reports are an important step in the path to CE Marking. Many manufacturers struggle to comply with European CER requirements; but Emergo has the experience with CE regulations and clinical literature reviews to help you prepare a fully compliant CER. IZiel completes the Clinical Evaluation Report (CER) as per the followi...

  Process Validation IQ, OQ, and PQ 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. IQ, OQ, and PQ process validation are sequential activities that manufacturers carry out to validate their manufacturing processes. IQ stands for Installation Qualification, OQ for Operational Qualification, and PQ for Performance Qualification. The purpose of process validation is to establish documented evidence that the production equipment is correctly installed, operates according to requirements, and performs safely. It is also to demonstrate that the manufacturing process under normal operating conditions will consistently produce conforming products. IZiel works with your team to assist you to complete all the following process validation activities ·          Process Valida...

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 Flexible ...

  Post-saleof 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 co...