Steps for Getting CE Marking

  A clinical evaluation report is important to healthcare because it confirms that a medical device has achieved its intended purpose. It also indicates that the medical device does not expose patients and other users to further risk. 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. IZiel  completes the Clinical Evaluation Report (CER) as per the following changes in revision Med-Dev Rev. 4 with focus on detailing and clarity on every step of the clinical evaluation process that has been conducted by the manufacturers and evaluators. Working in-tandem with our clients, we endeavor to provide every detail asked for and more, keeping a keen eye on objectivity, completeness and evidence-backed content, throughout the process.  

Until today, medical devices were complying with the Medical Device Directive to sell their products in Europe. However major amendments are made in the current MDD to keep up with the growing technological advances in healthcare and medical devices. Typically, all MDD-MDR transition projects initiate with Gap Assessment. Gap Assessment is a crucial activity during MDR transition & our team with engineering & regulatory expertise are well equipped to conduct this activity with an analytical mindset, resolve any regulatory concern and develop robust regulatory strategy for medical device manufacturers. IZiel team of specialists and quality professionals look forward to support more medical device companies to file their devices under the MDR 2017/745.

The top medical device consultants have relevant industry experience have relevant experience within the industry, knowledge of the right regulatory frameworks, and proven experience working on similar projects. Regardless of whether you’re trying to develop a regulatory strategy, prepare for submission or respond to the FDA, working with a consultant who’s succeeded in similar situations can increase your chances of a favorable outcome. IZiel implements an Outcome-Based Delivery Model to provide a complete solution from developing engineering documentation to receiving USFDA Approvals & establishment registrations thereafter. Our teams from USA & India collaborate to develop a Cost-Effective Model to complete USFDA Approvals for customers in USA, Europe and Asia. 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, ...

 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...

  Why is the modification in the regulation ( MDD to MDR Transition ) adapted? History : You may be aware of the breast implant scandal in France wherein instead of medical grade Silicon, a low-quality Silicon was used as a raw material for breast implants which got ruptured and there were several complaints filed which led to the recall of the device by the manufacturer. Because of these kinds of incidents, the MODIFICATION to MDD came into the picture and it’s called MDR, which is more comprehensive and detailed than MDD. How do we adapt to MDR? ·          Gap analysis while considering additional requirements of MDR. ·          Refer Annexure XVII of MDR MDR focuses on the safety and performance assurance of the devices placed on the market. MDR assures that the product causes no harm to the customers. Clinical and Non-Clinical testing methods include Clinical Investigation, PMCF studies, ...

Risk, risk assessment, estimation, evaluation, risk control, and risk management are very well defined in BS EN ISO 14971: 2019. This standard is used for medical devices, IVDR, and has become a harmonized standard for risk management in Canada. Risk management is defined as the “ Systematic application of management policies, procedures, and practices to the tasks of analyzing, evaluating, controlling, and monitoring risks .” What are the steps in the risk management process ? ·        Identify Hazards, Hazardous Situations in Production and Postproduction, Literature Reviews, Adverse Event Databases ·          Estimate and Evaluate the Related Risks ·          Apply Control Measures for Risks ·          Effectiveness Check ·          Residual Risks Acceptability Check ·     ...