CLINICAL EVALUATION REPORT

Name: HIGS
Brand: HIGS
Rating: 4.9 (5769 reviews)

The Clinical Evaluation Report (CER) is the conclusion of a clinical study and the clinical evidence of a medical study of a patient. Our potential Clinical Evaluation Report Writers of HIGS will be handling your report. We will put more hardwork and dedication into researching your clinical evaluation report writing process.

The in-house content writer will write the Clinical Evaluation Report. The general method of writing a clinical evaluation report is, writing each part of the section with History, Examination findings, investigations, and treatment.

TOP QUALITIES OF OUR CLINICAL EVALUATION REPORT WRITERS

hotel_class 10+ years of experience in writing a CER.
hotel_class Our CER writer has experience in writing CERs for medical device companies across the world, so, they are already familiar with processes and needs outlined in the regulations of a CER.
hotel_class Our team has clear medical and scientific knowledge that helps to write an effective clinical study.
hotel_class Our CER writers are detail-oriented
hotel_class Ability to meet deadlines
hotel_class They have a clear understanding of MEDDEV 2.7/1 rev 4.

HOW DO WE PREPARE A CLINICAL EVALUATION REPORT FOR MEDICAL DEVICES?

HIGS will write your clinical evaluation report with sufficient clinical evidence and benefits. Here we have listed possible information that can be included in the CER report,

Our Clinical Evaluation Report Writers…

chip_extraction The complete general information, i.e., device & manufacturer name.
chip_extraction Brief physical & technical description of the device.
chip_extraction Outline of the therapeutic & diagnostic claims with supportive evidence.

chip_extraction Clinical benefits and associated clinical outcome measure.
chip_extraction Summary & assessment of the clinical data.
chip_extraction Examination of the data to show the appropriate GSPR such as performance, safety, and acceptability of benefit-risk ratio.

REQUIREMENTS OF AN EVALUATION REPORT

A clinical evaluation report is an exhaustive assessment of pre and post-market clinical data appropriate to a medical device. The HIGS team will help you in writing your clinical evaluation report provided with a deep analysis of the performance of the clinical safety. To perform a clinical evaluation of the medical device, HIGS will research the following ‘6’ discrete stages. They are,

task_alt Your Scope
task_alt Your Plan
task_altIdentification of pertinent data

task_alt Appraisal of pertinent data
task_altAnalysis of clinical data
task_altFinalize the report

OUR PROMISED QUALITIES OF A CER

Well organized
Comprehensive
Clinical evidence
High-Quality
Informative
Error-free
Understandable

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HOW DOES HIGS WRITE AN EFFECTIVE CLINICAL EVALUATION REPORT?

The complexity of a CER can vary significantly. But, the result will be the same.

draw We write the clinical evaluation report of results that will be reader-friendly.
draw It will be written in simple terms.
draw It will be written and readable by third-party people.
draw It will have sufficient detail to understand the data and analysis.

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WHAT IS THE NEED FOR A CLINICAL EVALUATION REPORT?

If you plan to sell your medical devices in Europe or other countries, provide a Clinical Evaluation Report. Your Clinical Evaluation Report must be based on the clinical data from the existing literature, clinical experience, and clinical trials.

DIAL +916382814563 TO GET INSTANT ASSISTANCE IN WRITING YOUR CLINICAL EVALUATION REPORT

WHAT CAN WE DO FOR YOU?

chip_extraction Write Your CER

We prepare a new & novel CEP & CER

chip_extraction Update your existing CER

We help you update your CER regularly based on ongoing clinical evaluations.

chip_extraction GAP- analysis of your current CER

Identify the current state, determine the desired future state, identify the gaps, evaluate the findings & do an analysis.

chip_extraction Upgrade your existing CER

We help you to upgrade CER yearly. We help you upgrade your CER with the latest evaluation report.

chip_extraction Clinical Expert review

We provide a list of objectives & reviews. You can also state how the literature search and reference selection were done.

HOW DO WE PERFORM THE CLINICAL EVALUATION?

The clinical evaluation is completely based on a comprehensive analysis of available pre and post-market clinical data relevant to the intended purpose of a device in scope. Here, at HIGS, we perform the clinical evaluation study with the below given “4” stages of clinical evaluation. They are,

1- Describing the scope and planning of the clinical assessment
2- Distinguishing pertinent data

3- Appraisal of data sets for scientific validity
4- Analyze the data, whereby conclusions are reached.

CER: COMMON GAPS & CHALLENGES TO TAKE

1 Poor literature review
2 Missing critical documents related to CER
3 Inconsistency between essential documents
4 Input from a diverse expert team
5 Template compliant to MDR and MEDDEV 2.7/1 rev 4

THE SCOPE OF CER

Before beginning the clinical evaluation process, the manufacturer must explain the scope of the device according to the clinical viewpoint, nature, and history of the medical device. This plan will help you to outline the strategies & procedures utilized in the clinical evaluation of the device and present potential key factors determining the safety and performance of the device. This includes the scientific explanation for the design & mechanism of action of the medical device.

Here, we have included the real meaning of CER. They are,

Identifying the general safety & performance requirements that require support from the relevant clinical data.
A specification of the intended purpose of a device
A clear specification of intended target groups
A specification of the methodologies is used for examining the qualitative and quantitative characteristics of clinical safety.
The specifications of the parameters to be utilized for determining the efficacy of the benefits ratio for the diverse indications and the intended purpose of the medical device.
An indication of how benefit-risk issues concerning specific features like the utilization of non-viable animal or human tissues, are to be managed.

HOW “HIGS” WILL ANALYZE THE CER DATA?

It is important to analyze & present the study results about their quality safety, and performance. There are two ways in which data can be presented in a CER. HIGS uses the following methods to analyze the CER data. They are,

trending_upText-based summaries of individual studies
trending_upVisual summaries of pooled data
trending_upDevice description
trending_up CE marking status of the device
trending_up Risk management documentation

trending_upData sources & types to be used
trending_upInformation needed for demonstrating equivalence
trending_up Design, manufacturing, materials, or labeling changes.
trending_up A newly emerged clinical activity.
trending_up New data generated from PMS.

CER FILE AND ITS FACTS

HIGS will implement the following “4” stages of clinical evaluation in the report. They are,

1. SCOPE

The scope & context of the clinical evaluation includes the product being tested and any sizes and settings covered in the evaluation process. This comprises an explanation of the technology to which the device belongs.

2. APPRAISAL OF DATA

In this stage, the data is determined, and the validity of the data sets must be evaluated. This data set must be relevant to the clinical evaluation and how heavily it should be weighed in the overall evaluation.

3. IDENTIFICATION OF PERTINENT DATA

This contains any data produced by the manufacturer, including premarket clinical investigations, and the data from the literature.

4. ANALYSIS OF CLINICAL DATA

This is the actual analysis of the clinical data, and it includes the benefits & risks of the device. It explains the acceptability of the benefit or the risk profile.

DO YOU WANT HIGS TO CREATE A GOOD MEDICAL DEVICE CER?

Formulating a broad and effective Clinical Evaluation Report for medical devices involves numerous key steps and standards. HIGS Clinical evaluation report writers will implement the following. They are,

verified It will be adhering to MDR Article 61
verified It must follow MEDDEV 2.7.1 Rev. 4 guidelines
verified The medical device CER must be accurate, regardless of whether the data is positive or negative.
verified MDR CER Report must be detailed and capable of building confidence among NB reviewers and subject specialists.
verified The clinical evaluation report for established devices can rely on prevailing market data, and new devices need data from similar and equivalent devices.

DO YOU WANT TO CRAFT A CLEAR CONCLUSION FOR YOUR REPORT?

Here, HIGS gives a way to craft the final part of your report.

chip_extraction According to the current knowledge in the medical field, and available medical alternatives, the benefit-risk of the profile is concerned.
chip_extraction The device for human usage is to be shown through usability engineering endorsement. The user manual or information must be circulated along with the device.

chip_extraction Level of acceptance with manufacturer claims and foreseen discrepancies.
chip_extraction Unanswered questions or uncertainties derived during risk-benefit assessment and later accepted post-data interpretation of PMS consequences must be reported and justified completely.

CONTENT OF A CLINICAL EVALUATION REPORT

The CER written by the HIGS professional team will hold sufficient data that is to be read and understood by an independent party like a regulatory control or a notified body. It offers sufficient details for understanding the search standards. HIGS will include the following in your Clinical evaluation report. They are,

Summary
Scope of the clinical evaluation
General details such as manufacturer’s name, address, and responsible person.
Clinical background, current knowledge, State of Art.
The device is under evaluation. The type of evaluation is based on available scientific literature, clinical investigations, and more.
Summary & appraisal of the clinical data.
Analysis of the clinical data based on safety, acceptable risk-benefit profile, performance, and acceptability of side effects.
CER Conclusions
Qualifications of the responsible evaluators
Date of next clinical evaluation

HIGS- THE LEADING PROFESSIONALS OF CLINICAL REPORT & SUMMARY WRITING!

Our leading team of medical professionals possesses a wide knowledge of various regulations, standards, and guidelines. Our clinical report writers specialize in handling your report with clear interpreting, organizing, and presenting the clinical data in a clear & professional manner.

HOW DOES HIGS WRITE A CLINICAL REPORT OF A PATIENT?

HIGS will write the clinical report of a patient from the primary complaint to the current condition of a patient. Our writers will include the following in the clinical report of a patient. They are,

Family History
Occupational & social history
Medication & allergy
Findings of physical examinations

Laboratory test results
Date of last visit
Date of admission
Surgery details

HIGS Is Here To Help You From The Beginning Stage Of The Research To The End. You Can Have A Free Technical Discussion And Also You Can Talk With Our Experts. You Can Dial +916382814563 And You Can Mail Us To researchguidance@higssoftware.com To Get More Details.