Medical Device Software Validation

  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 CAPA.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. ·          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 ·          Demonstrate awareness of applicable re...

  All products meeting the definition of medical devices as defined by the EU regulations require CE marking before they can be sold in the EU. CE marking indicates that a product has been assessed by the manufacturer and meets EU safety, health, and environmental protection requirements. It is required for products manufactured anywhere in the world that are then marketed in the EU.  The product must comply with all the relevant MDD to MDR requirements of before affixing the CE marking to it. Although the compliance requirements are similar in many ways, the European route is thought to be less governmental, resulting in shorter times to market, greater acceptance rates of new devices, and lesser costs associated with obtaining conformity certification. While the benefits of obtaining a CE marking are significant, regulations are always subject to change. New modifications to the European medical device requirements are making the process more similar to that o...

 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. As the US Food and Drug Administration’s medical device and IVD review process becomes more complicated, partnering with an experienced  FDA consultant  can make a significant difference in your market authorization and compliance efforts. Upon completion of Engineering &  QMS Documentation , the regulatory team of IZiel conducts the predicate device search, comparative analysis and ensure all the necessary standards are complied with. Thereafter, IZiel team initiate the writing of 510(k) / PMA, which is verified and approved by our US Regulatory Consultants. Our highly experienced US regulatory consultants include Ex-FDA Auditors, have conducted 3500 + reviews and approvals and ha...

  Configuration management 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. IZiel Team would assist your team to – Analyse the proposed changes to product design for determining effect on overall product and / or system. Manage change orders to prepare for change authorization and documentation by company and / or subcontractor. Prepare reports of change impact on overall product and product lifecycle. Review and analyse released engineering change data and coordinates changes with engineering, quality, support, manu...