Project brief
Following a structured discussion with you, literature review objectives are defined and used in designing the search protocol.
Literature Search Protocols, SOTA Reviews & Data Analysis for EU & UK MDR
Systematic Literature Search & Reviews for all classes of medical device
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Effective literature search protocols & SOTA reviews form the heart of a compliant regulatory strategy
Our international team of over 50 medically-trained subject matter experts will apply their clinical acumen to your medical device literature search & reviews.
- Clinical insight & subject matter comprehension
- Evidence appraisal & analysis from professional clinicians
- Experienced objectivity & reviewer independence
- MedDev 2.7/1 rev 4 & MDCG-compliant service
- Direct oversight of project progress through an assigned lead writer
- Fully insured ISO & TOPRA-registered consultants
Effective EU & UK MDR literature search protocols designed by a specialist team
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.
- Literature Reviews for SOTA determination, Clinical Evaluation, adverse events characterisation, competitor analysis & more
- Sources sorted against inclusion criteria with tracking & exclusion reasons
- Structured appraisal & analysis
- Determination of safety & performance criteria from SOTA data
- Clinical context & background determination
- Identification of outcomes relating to frequency and severity of harms
We guarantee
Comprehensive literature search & reviews crafted around your objectives, delivered by subject matter experts.
- Quick & tailored quote with set prices & no hidden costs
- Fixed timelines with a commitment to meet your deadlines
- Direct access & transparency on project plan & process
- Completely customisable service tailored to your exact requirements
- No final payments until 100% client satisfaction
- Unlimited & free assistance with Notified Body review
Want to talk to an expert? Send us your details and we'll get back to you…
Our Clients say
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
Our literature search & SOTA appraisal process
We ensure alignment with your objectives, relevant regulatory guidelines and timeline expectations.
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Search protocol development
Clinical evidence identification, appraisal and analysis protocols are defined according to MedDev requirements.
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Literature extraction
PICO-research questions and search terms are defined and sources are extracted from a minimum of two clinical evidence databases.
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Screening
Identified sources are screened against inclusion / exclusion criteria and a justification is recorded for each excluded source.
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Detailed appraisal & analysis
An individual appraisal is performed against each identified source while arranging the review into a narrative incorporating background and foreground sections.
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Pooling of outcomes
As relevant, performance and safety outcomes are pooled, meta-analyses are performed, specific safety / performance criteria are identified and a SOTA determination is made.
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Literature review report
A comprehensive literature review report is produced, including records and outcomes of all above activities.
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Client review and revisions
Direct review and client feedback enables refinement and production of the definitive report.
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Post-submission
We then offer unlimited support with Notified Body reviews, standing 100% by our work and giving you complete peace of mind.
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Outcome
Our goal is full approval of your devices. Get in touch with our team for a free, confidential & no obligation discussion.
Our Clients say
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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
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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
An international team of medical experts & TOPRA registered RA professionals
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:
- Anaesthetics
- Cosmetic surgery
- Elderly care
- Emergency medicine
- General practice / family physician
- Intensive care
- Internal medicine
- Maxillofacial surgery
- Obstetrics / gynaecology & neonatal care
- Ophthalmology
- Orthopaedics
- Rheumatology
- Upper & lower GI surgery
- And many more…
What is a literature search & review?
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.
- Developing and working to a search protocol meeting requirements in MedDev 2.7/1 rev 4
- Capturing all relevant evidence sources for SOTA and subject device
- Tracking all excluded sources with justifications
- Conducting objective appraisal of included sources
- Extracting safety & performance benchmarks from SOTA
- Conducting an analysis comparing evidence relating to subject device with benchmarks
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.
Our Clients say
A comprehensive, detailed and highly professional service.
BGRegulatory Manager Manufacturer, UK
Related literature search & review services
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CER & CEP Writing Service
With a 100% CER success rate for submissions under the EU & UK MDR, our international team of over 50 medical writers are specialists in producing Clinical Evaluation documents.
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NCR response & remedial work
Received a Non-Conformance Report relating to a Clinical Evaluation submission? Our team has extensive experience in making necessary changes, re-working documents and preparing responses to Notified Bodies.
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CER Writing Training & Template
Learn the secrets of our successful Clinical Evaluation process and become a confident writer of CERs with our online CER Writing Training Course.
Contact us to discuss any of these services in more detail.
Are you looking for…
- Literature search & review support?
- A quote for our services?
- Help understanding your options?
Whatever you need, contact us today for a free & confidential discussion.
Our Clients say
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Regular meetings were implemented to ensure understanding of both parties and to discuss and address any findings within individual reports. We would engage the services again in the future should the need for further support arise.
PWHead of Clinical Governance & Regulatory Affairs Manufacturer, UK
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It was a pleasure working with you. We are completely satisfied with your service and look forward to working with you again.
JFChief Executive Officer SaMD Company, Denmark