Some companies are undertaking complete rewrites of their existing clinical evaluations, so concerned are they that the reports will be rejected at the next review cycle. The EU intends to change the formatting rules, however my European colleagues inform me the version of the guideline is still firmly in effect and that changes are likely to come slowly.
The Active Implantibles Medical Device Directive of discussed the essential requirement marketing spotlight hsbc case study The Medical Device Directive of discussed the essential requirement of clinical evaluations in Annex X.
But neither directive gave much information about format. Any CER that bore even a vague resemblance to what was described in the Directive was deemed to be acceptable. The variety of Frozen food business plan ppt that have crossed our desks has been remarkable.
However as time has passed the NBs have better understood their role in the evaluation process. With the issuance of a checklist for an audit of a Notified Body’s review process, NBs are being held accountable for their decisions and are refusing to accept reports that do not correspond strictly to the MEDDEV 2.
This is the format you are expected to follow for compliance. Reviewers work with a checklist at the back of the guideline when reviewing a CER and if a section or item is missing you may get a nonconformity, costing extra weeks of review time and lost sales opportunities.
What follows is a review of the recommended format for a CER. One leg is the literature review, a white paper literature review leg is the assessment of your risk management process, and the third leg is the assessment of any clinical investigations your firm has sponsored. The three “legs” are brought white paper literature review as attachments to a finalized report, the “seat” of the stool. In the opening paragraphs of the seat you must take care to identify white paper literature review what device s are covered by the report; identifying the devices by proprietary name, any code names assigned during device development one company used the code name “Kermit” because they white paper literature review to leap over the competition, and the manufacturer s of the device.
Your firm should assign or outsource a medical writer who will act as project manager for preparing the report, have authority to obtain and inspect all white paper literature review records and reports, and have authority to work with external services as needed. In our experience as consultants, it takes about hours of labor over a three month duration to write a clinical evaluation.
The description should cover information such as: You should think like the sales department of a successful department store: It’s useful to include diagrams, drawings, photographs, comparative tables, lists of animal safety testing, text boxes, and the white paper literature review.
These tools help the reviewer to grasp the essence of your technology without doing a lot of independent research. Don’t forget to white paper literature review the intended application of the device — single use or reusable; invasive or non invasive; implantable or not; duration of use or contact with the body; organs, tissues or body fluids contacted by the device; is the device used in the home — and describe how the device achieves its intended purposes.
Sometimes clients forget about the processing aids or white paper literature review substances used during the manufacturing process. Metal parts are routinely washed with solvents to remove Stanford Football Gear – Shop at College Football Store tissue fish from the sea.
Sometimes the final processing takes place in the physician’s office or lab. You should be able to demonstrate the absence of any inadvertent residue, or that any such residue does not interfere with safety or performance. You must clearly state the medical conditions indications and discuss the medical background for each condition. Reviewers are not experts in all fields of medicine.
What is a Literature Review?
Your goal as the medical writer is to remove all barriers to clarity, understanding, and full information. You then identify the target treatment groups and diseases for the medical conditions. Who are the patient groups that will be exposed to Essay dream holiday device? Let’s say the medical condition is pregnancy. The likely patient group is young, healthy women with no concomitant illnesses or genetic variants.
What are the diseases or disease subgroups for the medical conditions? Again, suppose the medical condition is pregnancy. You may be targeting pregnant women with diabetes, preeclampsia, or other issues. Finally, list the specific safety or performance claims intended uses you will make for the device and defend them.
You will have some strategic issues to deal with along the way. For example, do you want to mix device indications and, white paper literature review, cosmetic indications in the same clinical evaluation?
Or is it a smarter to submit an evaluation for medical use today and amend it for white paper literature review use in the white paper literature review Context of the evaluation Outline the developmental context for the device. The information should include whether the device is based on a new technology, a new clinical application of an existing technology, or the result of incremental change of an existing technology. The amount of information will differ according to the history of the technology.
Where a completely new technology has been developed, this section would need to give an overview of the developmental process and the points in the development cycle at which clinical data have been generated. For example, a manufacturer developed an resorbable container in which a patient’s tissue was held in place until it could take hold and grow, as opposed to being held in place with a sling of sutures. The CER included data about both the resorbable container and preparation of the patient’s tissue.
For a long standing technology, a shorter description of the history of the technology with appropriate references could be white paper literature review. For example, the CER for a new wound dressing would not need to white paper literature review the history of wound dressings all the way back to the Romans.
Clearly state if the clinical data used in the evaluation are for an equivalent device. Identify the equivalent my brother sam is dead compare and contrast essay s and provide a justification of the equivalency, cross-referenced to the relevant non-clinical documentation that supports the claim. In particular, describe any special design features that pose performance or safety concerns, e. These features should be identified in the device risk management documentation as requiring assessment from a white paper literature review perspective.
Sources of data Outline the considerations white paper literature review to choose the clinical databases for the evaluation.
Provide an outline of the search and retrieval process for scientific literature, including the actual key words and search strings, and cross-reference these to your white paper literature review procedure for searching and reporting the literature you have one, of course.
Summary of the clinical data and appraisal Provide a tabulation of the clinical data used in the evaluation, categorized according to whether the data address the performance or the safety of the device in question. Within each category, order the data according to the importance of their contribution to establishing the safety and performance of the device and in relation to any specific claims about performance or safety.
Additionally, provide a brief outline of free research papers an attachment to the CER.
Identify the datasets that are considered to be the most important in contributing to the demonstration of the white paper literature review performance of the device and, where useful, particular performance characteristics. You might include the number of patient-days of exposure, if some patients are exposed or followed longer than others. You should explain if patients problem solving da tasca lost to follow-up. Provide a summary of device-related adverse effects, paying particular attention to serious adverse device effects.
Provide specific comment on whether the safety characteristics and intended purpose of the device require training of the end-user. Does the literature cover all the hazards and other clinically white paper literature review information that may impact on the use of the device?
Implanted or home use devices require special consideration, describe how patients will be educated on the care and use of their device and how they can obtain help or additional information, especially outside of business hours. argumentative essay on military spending whether the risks identified in the risk management documentation have been addressed by the clinical data. For each proposed clinical indication state whether: Here we discuss the process as it is usually performed at CDG.
Do the clinical data reveal any new risks not already discussed?
white paper series september Roger S. Ulrich Craig Zimring, PhD Xuemei Zhu Jennifer DuBose, MS Hyun-Bo Seo Young-Seon Choi Xiaobo Quan Anjali Joseph A Review of the Research Literature on Evidence-Based Healthcare Design Healthcare Leadership 5 of 5. abstract Literature Review on Evidence-Based Healthcare Design.
ISO ] Preparing a spreadsheet listing the clinical benefits and risks is a good strategy for grasping their scope. Describe the nature of each benefit and risk in a column and the anticipated outcome in the white paper literature review column. Indicate the anticipated frequency of occurrence of each benefit and risk in column three. In column four, identify type of adverse effect likely to occur. Next, indicate if the risk would result in a mild, moderate, or severe adverse effect; for example, a headache rarely meets the criteria of serious, yet it could be severe.
Sometimes we indicate if the risk is white paper literature review with the procedure or the device itself. Finally, indicate how the risks have been mitigated. We are trying to gather together as much information as possible to understand the overall risk of the device.
Subjectively, we then compare the benefits and risks to determine if one outweighs the other. A number of factors may come into consideration. For example, let’s say that two patients suffer from spondylolisthesis, a defect in the spine which causes vertebra to slip to one side of the body. Let’s also assume that one patient is in her thirties and the other in her seventies.
Knowing that it takes a year to recover from white paper literature review surgery, spinal fusion may make sense for the younger patient for whom pain management over fifty years of remaining life is unreasonable.
Here you will find a thorough and detailed itemization of the points you should include in the report. If you meet all of the criteria in the checklist, a Notified Body will have little power to reject your evaluation based on format alone. A guide for manufacturers and Notified essay rubric 4th grade