Project brief
Following a structured discussion with you, literature review objectives are defined and used in designing the search protocol.
Systematic Literature Search & Reviews for all classes of medical device
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Our international team of over 50 medically-trained subject matter experts will apply their clinical acumen to your medical device literature search & reviews.
Each project is led by TOPRA-registered regulatory professionals who manage teams of medical reviewers with clinical experience in the field of the subject device.
Comprehensive literature search & reviews crafted around your objectives, delivered by subject matter experts.
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Mantra Systems have provided outstanding quality literature search reports and State of the Art appraisal reports for our Oral Care Medical Devices. Mantra Systems have worked closely with us to allow our pre-existing Clinical Evaluation Report structures to be updated by them, thus minimizing document structure changes observed by our Notified Body. The reports delivered by Mantra Systems have fully met our needs and those of our Notified Body. Mantra Systems have worked hard to meet our specific needs and have been a pleasure to work with; I would thoroughly recommend them.
TDDr. Trevor Day Principal Scientist Procter & Gamble, UK
We ensure alignment with your objectives, relevant regulatory guidelines and timeline expectations.
Following a structured discussion with you, literature review objectives are defined and used in designing the search protocol.
Clinical evidence identification, appraisal and analysis protocols are defined according to MedDev requirements.
PICO-research questions and search terms are defined and sources are extracted from a minimum of two clinical evidence databases.
Identified sources are screened against inclusion / exclusion criteria and a justification is recorded for each excluded source.
An individual appraisal is performed against each identified source while arranging the review into a narrative incorporating background and foreground sections.
As relevant, performance and safety outcomes are pooled, meta-analyses are performed, specific safety / performance criteria are identified and a SOTA determination is made.
A comprehensive literature review report is produced, including records and outcomes of all above activities.
Direct review and client feedback enables refinement and production of the definitive report.
We then offer unlimited support with Notified Body reviews, standing 100% by our work and giving you complete peace of mind.
Our goal is full approval of your devices. Get in touch with our team for a free, confidential & no obligation discussion.
Your service surpassed our expectations and added value across our organisation. We feel much better placed to prepare for the MDR.
KWChief Executive Officer SaMD Company, UK
All aspects of communication from Mantra Systems have been excellent from initial contact to the conclusion of the work. There was excellent communication during the projects, included reviews and discussions helping to maintain the momentum and provide the required outcomes.
DSRegulatory & QA Manager Manufacturer, UK
A literature search & review is a structured extraction, appraisal and analysis of published clinical evidence. They are essential in performing Clinical Evaluation and form vital inputs to Risk Management activities.
Literature searches & reviews have 4 key components:
1. Evidence identification - through the use of research questions and search terms, sources are extracted from clinical evidence databases and screened against inclusion / exclusion criteria.
2. Appraisal - the determination of strength of a clinical study and its relative contribution to the literature review.
3. Analysis - determination of outcomes, meaning and 'message' of the reviewed evidence.
4. SOTA determination - having reviewed the clinical evidence, it is possible to determine the state of the art in the clinical field, another vital component of Clinical Evaluation.
Our team of professional medical writers can assist you with all aspects of literature searches & reviews, bringing the highest standards of clinical evidence appraisal and analysis.
Working with Mantra Systems gives you access to an international network of dedicated literature search & review specialists.
Contact our team today for a free, no-obligation exploratory discussion.
Please thank all of your team for their brilliant efforts. Your standard of service, response time, and rigour were outstanding and I would strongly recommend you to any other potential client.
ABQuality Advisor Manufacturer, UK
We serve an international client-base covering all classes of medical device across a wide range of clinical fields.
Our clients are based around the world, hailing from the UK, Europe, North America, Central America, Asia and the Middle East, and vary in size from pre-market start-ups to stockmarket-listed multinationals.
Mantra Systems have worked hard to meet our specific needs and have been a pleasure to work with; I would thoroughly recommend them.
TDDr. Trevor Day Principal Scientist Procter & Gamble, UK
Mantra Systems has a dynamic team of subject matter experts with extensive experience in designing literature search protocols and conducting literature reviews for medical devices under EU & UK MDR.
Our international team offers a market-leading service as an essential component of many vital regulatory activities. We are also skilled in conducting evidence-based competitor analyses, offering insight into potential commercial advantages based on published data.
We match each project to subject matter experts who work within the clinical field of the device under evaluation, along with experienced regulatory professionals to lead the project.
We have over 50 subject matter experts based in the UK, Europe, USA, Canada, South Africa, and India. Their specialities include:
A comprehensive, detailed and highly professional service.
BGRegulatory Manager Manufacturer, UK
Whatever you need, contact us today for a free & confidential discussion.
Mantra Systems provides professional EU & UK MDR medical device regulatory consulting services to companies seeking compliance & market access for any class of medical device.
Our international team of medically-trained consultants will bring unrivalled clinical evidence appraisal & analysis to your medical device regulatory strategy.