Medical device manufacturers receive observations (Form 483 Compliance) and / or warning letters on completion of USFDA Audit. The document outlines any violations of Good Manufacturing Practices (GMP’s) such as the facility, equipment, processes, controls, products, employee practices or records. Companies may also undertake product remediation to resolve issues that they are aware of in their product design and development process. The 6 biggest ways an experienced compliance and remediation consulting firm can help those recovering from a Warning Letter (Form 483 Compliance) or FDA Warning Letter·        Objective, un-biased perspectives ·        A comprehensive understanding of CAPA·        An eye for spotting compliance gaps you may otherwise miss·        Knowledge of an ever-changing regulatory environment ·        Strong relationships with FDA·        Access to former FDA staff IZiel adopts an analytical mindset thus enabling us to root out all possible non-conformances in a regulatory submission. Thereafter, IZiel team works with their regulatory team in USA to complete the submissions (510k or PMA) for USFDA Approvals.

As the US Food and Drug Administration’s medical device and IVD review process becomes more complicated, partnering with an experienced USFDA Regulatory Consultants can make a significant difference in your authorization and compliance efforts& process. Medical Device Manufacturers require USFDA Approvals to sell their products in USA. IZiel implements an Outcome-Based Delivery Model to provide 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. Thereafter, IZiel team initiate the writing of 510(k) / PMA, which is verified and approved by our US Regulatory Consultants.

FDA 510k Consultants or USFDA Consulting Firms can help you navigate the complete process for any medical device Class I, Class II, and Class III by completely understanding the device and by relating any possible risks. Good and educated specialized experts assure briskly 510k clearance.  Still, please read below to understand how we support customers to prepare and submit the 510k File briskly with lower chance of entering an original “Refuse to Accept” (RTA) hold or an “Additional Information” (AI) request from the FDA, If you're a manufacturer or a specification inventor. Thereafter, IZiel team works with their regulatory team in USA to complete the submissions (510k or PMA) for USFDA Approvals. Following illustration would help you to understand the requirements of USFDA Approvals –

It is compulsory to have CE marking for all category of medical devices. This requirement is quite old and it was there even in MDD. However, with some additional new requirement in MDR, CE marking is slightly affected and one has to decide strategy for CE marking when transposing from MDD to MDR. Once the classification is complete one can know which regulation will apply. This will also be a major change from MDD to MDR.

As part of regulatory compliance, medical device manufacturers need to create and maintain a Clinical Evaluation Report (CER), a document essential for CE Marking. Here are expert tips on what to consider defining a robust CER strategy. The aim of a CER is to reduce the risk that the users and patients are exposed to when using a medical device. Ensuring thoroughness and scientific accuracy at every step of collating data and presenting it in the CER are our prime objectives, and receiving approval is the clear endpoint for every report we create. EU MDR identifies the use of clinical investigations as a method of assessing the benefit-risk ratio of medical devices.

The aim of a CER is to reduce the risk that the users and patients are exposed to when using a medical device. 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. The complexity of a Clinical Evaluation Report can vary significantly, but the result should be the same. 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.

What is a dietary supplement? Some supplements can help assure that you get enough of the vital substances the body needs to function; others may help reduce the threat of disease. Who is responsible for the safety of dietary supplements? The manufacturers and distributors of dietary supplements are responsible for making sure their products are safe BEFORE they go to market. This means that FDA does not keep a list of manufacturers, distributors, or the dietary supplement products they sell by FDA.

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 submissions (510k or PMA) for USFDA Approvals. Read more@ https://iziel. com/usfda-consulting-firms/

When looking at the clinical evaluation of a new device, the available data will typically be limited. 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. For high-risk devices, CERs need to be updated annually at the minimum, while low-risk and well-established devices can update CERs every 2-5 years. Measurable objectives for CER: The objectives of the CER must be clearly linked to specific endpoints on the safety, performance, and risk-benefit aspects.

The manufacture of safe and high- quality pharmaceutical products require good manufacturing processes. This is the thing of Process Validation, i. The way to achieve this is through the Three Stages of Process Validation for medical devices. Why is Process Validation Testing Important? To ensure customer satisfactionTo be confident about the productTo fulfil the client’s requirement until the optimum capacitySoftware acceptance from the end-userPhases of Process Validation Testing Process –·        Define Requirements·        Team Selection·        Maintaining Documentation·        Validation Report·        Incorporation of changesValidation testing techniques is mainly about analysing the in-depth functionalities of the software product.

The Food and Drug Administration's regulatory approaches to marketing approval of the products it regulates are as differed as the products themselves. These difficulties are mandated by the acts FDA enforces and the relative pitfalls that the products pose to consumers. The Agency does thispre-market review for new human drugs and biologics (similar as vaccines, blood products, biotechnology products and gene curative), complex medical devices, food and color complements, infant formulas, and animal drugs. Our teams from USA & India collaborate to develop a Cost-Effective Model to complete USFDA Approvals for customers in USA, Europe, and Asia. Thereafter, IZiel team initiate the writing of 510(k) / PMA, which is verified and approved by our US Regulatory Consultants.

IZiel Healthcare provides Process Validation for Medical Devices which includes IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification), TMV (Test Method Validation) etc.  Our robust Software Validation approach is aligned to IEC 62304 starting with requirements management alongwith risk management & traceability. Read more@ https://iziel. com/process-validation-for-medical-devices/

For each process step, define the process requirements. Within a lifecycle approach to process validation, employing a risk-based decision making throughout that lifecycle, helps identify critical process parameters throughout the lifecycle as opposed to only certain stages of the process Operational Qualification (OQ) –  Operational Qualification involves using the results of the Process Characterization studies and determining a well optimized process window. 5 lot of input materials or parts are taken, and the process nominal setting is challenged with this normally expected lot to lot variations. A high process capability is expected out of PQ run data since this represents long term process capability and stability. Test Method Development (TMD) & Validation (TMV)IZiel can provide support in the development and validation of Test Methods for inspections for both receiving and during in-process manufacturing.

What is Process Validation? The FDA defines process validation as, “the collection and evaluation of data, from the process design stage through marketable product, which establishes scientific substantiation that a process is able of constantly delivering quality product”. A foundational tenet of this FDA guidance document is the lifecycle conception. The lifecycle approach is concerned not only with the original drug development processes; but also, the establishment of marketable manufacturing and routine marketable product until discontinuation of the product. IZiel works with your team to assist you to complete all the following process validation activities for your medical devices.

From design, to engineering, to testing, and beyond, your medical device risk management process is an integral part for every phase of the design. Still, this can lead to your system lacking certain mitigations if your medical device risk management process isn't done rightly. Since having these mitigations and good practices are core to the FDA & CE approval process as USFDA Regulatory Consultants, you need an active medical device risk management process. Using Experience and Knowledge to Produce A Balanced Medical Device Risk Management Process Although it's important to have a active risk management process, if you spend too important time designing your process it can negatively affect your budget and timeline. It entails going through risk analysis, a risk evaluation, risk mitigations, and a residual risk analysis and operation.

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 submissions (510k or PMA) and resolve queries, if any, from USFDA. Read more@ https://iziel. com/regulatory-remediation/