Steps for Getting CE Marking

  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 reg...

  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 ...

  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 have ex...

  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,...

Mergers & Acquisition in the healthcare industry has been strong in recent years and is expected to grow. Acquiring a new company or product line can have a positive business impact, but it also comes with implementation, process, quality & regulatory challenges. Especially, in the medical device industry, failure to comply with regulations can result in the loss of authority to deliver products and services. While the impact of COVID-19 on these deals is yet to be felt, it remains an advantageous avenue for organizations to pursue. But what are the common issues in healthcare mergers and acquisitions?   ·          Failed Cultural Integrations This type of issue has the potential of increasing operational costs. Staff are unsure about the correct working procedures or administrative processes, agreed upon by the integrated management but not accurately communicated business wide. This could result in mismanaged patients, poor r...

  Before introducing a new medical device onto the market, manufacturers should have a high degree of certainty that their manufacturing processes have the proper controls in place to produce products that are safe and meet specified user, technical, and regulatory 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. IZiel provides complete expertise in process validation for Medical Devices and assists medical device manufacturers to consistently meet required parameters through their optimized manufacturing process. IZiel works with your team to assist you to complete all the following process validation activities ·          Process Validation Master Plan (PVMP) ·       ...

  Mergers & Acquisition in the healthcare industry has been strong in recent years and is expected to grow. Acquiring a new company or product line can have a positive business impact, but it also comes with implementation, process, quality & regulatory challenges. Especially, in the medical device industry, failure to comply with regulations can result in the loss of authority to deliver products and services. Because of this, it can be difficult for hospitals and healthcare organizations to know whether they should partner, when to partner and what type of organization to partner with. There are a few things every organization needs to think about before they get started - ·          Before considering a partnership, first step back and evaluate your organization’s needs, goals, and long-term strategy. ·          After a thorough self-review, deciding what type of partnership to pursue sh...