Steps for Getting CE Marking

 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. The FDA medical devices have been classified into 3 classes. Class I: They are low-risk devices. Class II: They are medium-moderate risk devices. Class III: They are of high risk, generally life-supporting and life-sustaining. IZiel  adopts an analytical mindset thus enabling us to root out all possible non-conformances in a regulatory submission. IZiel works in collaboration with your team to develop the complete Design History File (DHF) including requirements management, risk management, process validations and software validations using robust design controls process and quality system procedures. Thereafter, IZiel team works with their regulatory team in USA to complete the submiss...

Software Verification and Validation (Software V&V) is an integral part of software design that spans all the development stages as specified in IEC 62304 which addresses the Software Development Life Cycle (SDLC) of medical software and software embedded within medical devices. Software Verification is to test if the software was designed as per requirements and Software Validation is to test if the right product was built for the user. Medical device software validation generally occurs during or at the end of the development cycle.  The difference between Software Validation & Software Verification can be answered by asking these mentioned questions: ·          Verification: Are we building the product, right? ·          Validation: Are we building the right product? Software validation is a process of checking if the product will meet the customer’s actual needs, while verificati...

  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...

  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. 6 Requirements of a Clinical Evaluation Report for Medical Device Manufacturers – ·          Scope and plan ·          Identification of pertinent data ·          Appraisal of pertinent data ·          Analysis of the clinical data ·          Finalize the report ·          Physician Review & Approval   After data analysis, the evaluation report should summarize the data analysis. This report should provide strong clinical evidence for conformity assessment so the device can be app...

  Manufacturers are expected to follow the quality system requirements described in FDA 21 CFR part 820 This document guides to govern the design, manufacture, packaging, labelling, storage, installation, and servicing of medical devices intended for human use. The requirements in 21 CFR Part 820 are meant to ensure the safety and efficacy of medical devices sold in the US marketplace. FDA conducts regular inspections of medical device manufacturers to ensure compliance with these regulations. The inspection process, known as the Quality System Inspection Technique (QSIT), evaluates a company’s internal quality processes to determine whether they are in alignment with or in violation of these regulatory requirements. If any violations are discovered, the inspecting agent from FDA will issue in the form of 483 Inspectional Observations, Warning Letters what is applicable   Here are the most common mistakes companies run into with FDA 21 CFR Part 820: 1. ...

  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...

  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 specialized information. Configuration Management must include – 1.        Enterprise or Unified Supply Cha...

  The quality standards of medical devices consist of many aspects such as design control, risk management, vendor management etc. In this blog, we are going to discuss the importance of risk management for medical devices and steps to implement it during the product development stage . Risk management is an integral part of the medical device product development lifecycle. It helps medical device developers ensure that the product is reliable, works as expected and causes no harm to the patients, operators, or the environment. In other words, the main purpose of the risk management cycle is to reduce or mitigate the chances of failure in the product. Steps Involved  for Risk Management ·          Risk Management Framework & Planning ·          Risk Analysis ·          Risk Evaluation ·          Risk Control · ...