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In subsequent revisions of the guidelines, the CDSCO may also realign these definitions and put all
the medical devices under one common umbrella, making the rules and norms for all these devices
similar. For each medical device that is put on the market, a Post-Market Surveillance (PMS) system
must be maintained as part of the quality management system (QMS). Achieving MDR-Compliant
Literature Reviews for Medical Devices The MDR regulation outlines specific requirements for the
literature review — a robust process of executing evidence-based research queries that describe
medical device product safety, benefit, and risk. If you put your search term in quotation marks, “”,
the search engine will search for the search terms in that exact context and order. For many
companies, especially Small and Medium Enterprises (SMEs), the data retrieved from literature
searches will represent most, if not all, of the data collected. We guide startups from start to finish in
their medical device compliance. India-based, Leading Global Medical-Technology Company. In
Stage 2, your focus will turn to choosing the right data among the data sets you have found. Below
are five practice-changing medical literature updates from my talk that you don’t want to miss. Risk
Identification and Analysis in the Development of Medical Devices The process described in this
document applies to risks associated with a medical device, such as risks related to biocompatibility,
data and systems security, electricity, moving parts. These may act as a reference for future updates
in IMDR guidelines and are discussed in Way Forward section. If our above questions meet your
queries, then you have landed to the right destination. Then, content is checked with advanced
plagiarism detection tools to ensure a 100% Turnitin pass. However, Clinical investigation is not
required to grant the import license, if the device is already marketed for at least 2 years in Australia,
Canada, Japan, Europe or the United States and the respective CLAs are satisfied with the available
clinical evidence. The Power of a Robust Scientific Literature Synthesis Team: Manufacturers
navigating the intricate realm of medical devices and IVDs require more than a routine literature
review. The first is in CERs, as outlined in Chapter VI and Annex XIV, Part A. Again, establishing
technical, clinical, and biological equivalence for each device SKU is critical to justifying these
groupings. Check a list of sample literature review documents below and learn writing custom
literature reviews. Unfortunately, there is no single method for weighting clinical data. Our review
shows that the wearable medical devices developed so far have been designed for use on all parts of
the human body, including the head, limbs, and torso. While most publications are available in
English (e.g., 93% on MEDLINE), make some attempts to do basic searches in French, German, or
Japanese using online translation tools. Manufacturing and monitoring of medical devices are highly
regulated activities. Ultimately, the literature review supports CERs and post-market clinical follow-
up (PMCF) reports. Hire clinical evaluation experts and literature search specialists on Kolabtree. The
PCI DSS standard protects quick and smooth transactions. Fill out the form, provide task
specifications, and get an overview compliant with them. The first step is to create a robust clinical
evaluation plan. This is time-consuming and you might even be in a position of paying to access
publications. Also, you should conduct at minimum two search results. You can, of course, create
your own rating system with more factors, and you could weight these factors as well.
To obtain the best experience, we recommend you use a more up to date browser (or turn off
compatibility mode in Internet Explorer). Step Three: Write the Literature Search Review Report
Finally, you can write the Literature Search Review Report which contains the results of your search
that address safety, performance, benefits to the patient, side-effects, adverse reactions, state of the
art of the device in question. Federal government websites often end in.gov or.mil. Before sharing
sensitive information, make sure you're on a federal government site. Analyzing Your Medical
Device Clinical Datasets and Drawing Conclusions Anyone who has ever researched and compiled
an entire European clinical evaluation report knows that the devil is in the details. We found that 48%
of all papers did not mention any health facility or service analyzed, while 25.3% analyzed homecare
services. General Director, Regulatory Affairs Russian Based Healthcare Software Development
Company Device. Some of them are essential, while others help us improve this website and your
experience. These documents are distinct from one another and may only apply to specific device
risk classifications; however, they do sound similar and can be easily confused with one another. In
addition to the apparent challenge of keeping up with new content, there is another problem that
many researchers face: understanding the context, methods, and goal of the research being
presented. This recipe becomes the literature search protocol. It also ensures neither the research
analysis was done before nor it is a replication study. The clinical data include current knowledge of
the condition to be treated, published literature about the target device and any equivalent devices,
information held by the manufacturer about pre-clinical and clinical investigations, risk management,
post-market surveillance, and the instructions for use. For each document you appraise, you are
required to document your appraisal of it to the point that it could reasonably be reviewed by others.
We can obtain clinical evidence for the literature review for your new medical device or we can
update the literature review of a CE-marked or legacy device to create an MDR compliant
document. Keeping pace with the requirements, these were amended as Medical Devices
(Amendment) Rules, 2020, which has come into force in April 2020. Beating the Beast: Best Current
Pharmacological Modalities for Treating Covid. Time to accelerate integration of human factors and
ergonomics in patient safety. Our review shows that the wearable medical devices developed so far
have been designed for use on all parts of the human body, including the head, limbs, and torso. FDA
defines 3 types of Investigational Device Studies—. The MDCG agrees with this view: “Abstracts
lack sufficient detail to allow issues to be evaluated thoroughly and independently, but may be
sufficient to allow a first evaluation of the relevance of a paper. The role of the user within the
medical device design and development process: medical device manufacturers’ perspectives. Article
1(a) of Annex XIV in the MDR provides additional detail about what the clinical evaluation plan
should include. Need help with literature reviews for medical devices. The MDR furthers tightens
the screws for Class III and implantable devices, requiring a more in-depth assessment and making it
more challenging to leverage competitor data for new devices. Full Name Business Email Contact
Number Message I have read Privacy Policy Leave this field blank Partner With Us You must have
JavaScript enabled to use this form. IVDMD: In vitro Diagnostic Medical Device; IVDs: In vitro
Diagnostics; MD: Medical Device As per the IMDR, rules are applicable to both medical devices and
IVDMDs that: Can be licensed for-import; manufacture for sale or for distribution; and sale, stock,
exhibit or offer for sale May be manufactured for the purpose of clinical investigations, test,
evaluation, examination, demonstration or training. Here are some of the aspects that need to be
included in your CER scoping process. The most well-known operators are AND, OR, and NOT.
FDA classify Medical Devices and how to report device problems A Systematic R. Quotation marks
and round brackets are also useful for improving the quality of the search results.
Comparison of low-complexity fall detection algorithms for body attached accelerometers. When that
blood pressure reading was repeated at the end of the visit, over 50% of the patients had normal
blood pressure readings. On that stage we excluded publications that are obviously not relevant on
the basis of the contents of the abstract or title. Results: A total of 82 relevant papers drawn from
960 papers on the subject of wearable devices in health care settings were qualitatively analyzed, and
the information was synthesized. Hope we can work together on other projects. ? Key Accounts
Manager. Also, presentations made at industry conferences may provide information that is not
available (or has not yet been published) online. Moreover, our literature review writers identify the
current research gap and help you relate your findings to previous research. Also, it helps in marking
the loops or gaps of previous research. The results themselves are generally in the form of a list of
citations or data, with descriptive indexing tags and other key information. Beating the Beast: Best
Current Pharmacological Modalities for Treating Covid. But also, Medline, and BioMed Central are
considered top research informatic solutions for retrieving medical device literature and can be used
by anyone. The most technologically advanced solution is not always the State-of-the-Art. Users can
search that index to find material that has been pre-screened for them by the. Document all the
references You have to keep the lists of all your references somewhere. Trusted by Leading
Organizations At Freyr Solutions, we're proud to have partnered with a diverse range of industry
leaders. France-based, Leading Global Supplier of Women Healthcare Products Company. As a
knowledge-driven and strategically located and dependable outsourced partners, we aspire to
establish a long-term relationship with all clients. Screen the full text of the identified and selected
relevant publications for safety and performance data. Always capture reasons for the inclusion and
exclusion of your literature There is a big chance that auditors ask you why you excluded a certain
study. So, all university and college students can use our sample literature reviews for reference. If
someone reads the Section Literature Search Protocol and follows it, the same list(s) of publications
should be retrieved. As mentioned earlier, successful literature reviews depend on the proper framing
and subsequent refinement of search criteria. To fulfill this gap, Central Drug Standard Control
Organization released Indian Medical Device Rules, 2017, which are the new regulations for medical
devices in India. This “scoping” process is vital because you will need to explain and defend it to
your Notified Body, and you will need to replicate it in the future. Analyzing Your Medical Device
Clinical Datasets and Drawing Conclusions Anyone who has ever researched and compiled an entire
European clinical evaluation report knows that the devil is in the details. Once you read it, you will
not need a second document or guidance for writing a custom literature review. This is a preview of
subscription content, log in via an institution to check access. We've built Formwork, and it even has
a free version. We are satisfied. ? Director of Regulatory Affairs. More Features Connections Canva
Create professional content with Canva, including presentations, catalogs, and more.
In addition to daily health and safety monitoring, the focus of our work was mainly on the use of
wearable devices in clinical practice. But also, Medline, and BioMed Central are considered top
research informatic solutions for retrieving medical device literature and can be used by anyone. The
MDR went into effect on May 26, 2021, making it critical for device makers who are not yet in
compliance to address the new regulatory requirements outlined in this highly detailed and more
rigorous regulation. You are a high schooler who deals with a literature review for the first time. I
would rather come back to refine it after I’m done with the Clinical Evaluation Report. Potentially
relevant papers were then compared to determine their relevance and reviewed independently for
inclusion. The first step is to create a robust clinical evaluation plan. Federal government websites
often end in.gov or.mil. Before sharing sensitive information, make sure you're on a federal
government site. Are you searching Sample Literature Review examples. Unfortunately, there is no
single method for weighting clinical data. In addition, the MDR mentions “relevant specialist
literature” or “databases”. We couldn’t have achieved it without your able guidance and experience.
? Managing Director. We can review and trim down your documents to ensure conformity so that
your clinical evaluation passes the audit. Separately define and track search terms used, database
sources, date parameters, etc. EU MDR Literature Search Protocol The following phases constitutes
for EU MDR literature search protocol process: - At Freyr we conduct a systematic and exhaustive
medical device literature search protocol and review across various databases, including PubMed,
Embase, and Cochrane, to identify relevant studies and publications related to your specific medical
device. Screen the full text of the identified and selected relevant publications for safety and
performance data. Beyond our premium products, benefit from personalized wellness consultations
for tailored solutions and exclusive health events. Hope we can work together on other projects. ?
Key Accounts Manager. When I do this in my practice, patients’ blood pressure has returned to
normal well over 50% of the time. Evidence Based Medicine Master degree Course (Lecture 1):
Formulation of clin. Monitor for New Literature and Adjust the Research Question, If Necessary
Learn How Literature Review Automation Improves CER and PER Program Management.
Responsible innovation: a complementary view from industry with proposals for bridging different
perspectives. With the execution of IMDR in 2018, India has paved a new path in the field of
medical devices. Our consultants are also available to help you with EU CER development and gap
analysis. Knowledge of regulations, Open Communication, Timely followups with my team and
Professionalism. The rules are a positive step and encompass most of the European Union (EU)
approval process, which mandates that the devices are safe and performs its intended function. Is all
data generated, mentioned, and summarized in the report. David L Sackett, William M C Rosenberg,
J A Muir Gray, R Brian Haynes, W Scott Richardson. If you have the fear of not missing references
or are willing to explore new fancy ways of deriving existing knowledge and have resources for that,
you might want to consider natural language processing (models developed by Hugging Face,
OpenAI) or network-derived tools (Inciteful, Open Knowledge Maps, to name a few). As a result,
the PMS plan will impact multiple other QMS records, including the CER, risk management
procedures, corrective and preventive action (CAPA) procedures, trend reporting, PMCF, and
instructions for use (IFUs).