Literature Search for Medical Devices and IVDs
Why Companies Choose NAMSA
Of Our Writers Hold Advanced Degrees (MSc, PhD, MD)
Medical Device Clinical and Regulatory Specialists on Staff
Consultants with Previous US FDA or EU Notified Body Experience
Medical Device Clients Served Each Year
Your Evidence Starts Here: NAMSA’s Literature Search Expertise
Are you confident your clinical and regulatory documentation is built on a strong scientific rationale that can withstand regulatory scrutiny? At NAMSA, our Literature Search Services are designed to support every stage of your medical device’s lifecycle – from early development to post-market surveillance, with sound scientific evidence. Whether you’re preparing a Clinical Evaluation Report (CER), responding to regulatory requirements, or designing a clinical study, our literature searches provide the evidence you need to move forward with confidence. We conduct literature searches for a wide range of purposes:
- Scientific publications (e.g., peer-reviewed medical journal articles, systematic literature reviews, and meta-analyses)
- Clinical evaluations under MDR
- Performance evaluations under IVDR
- PMCF under MDR
- PMPF under IVDR
- Establishing state-of-the-art for new devices
- Supporting FDA submissions (e.g., 510(k), De Novo)
- Clinical study design and performance goals
- Premarket clinical evidence
Systematic Literature Searches
We don’t just perform literature reviews, we deliver regulatory-grade, systematic literature searches that meet the highest standards of scientific rigor and compliance. We specialize in systematic methodologies aligned with MDR, MEDDEV 2.7/1 Rev. 4, and PRISMA guidelines, ensuring your submissions are robust, compliant, and ready for scrutiny by notified bodies and regulatory agencies.
Our systematic reviews follow a transparent, reproducible, and audit-ready process, including:
- PICO-based question design to ensure clarity and focus
- Protocol development with predefined inclusion/exclusion criteria
- Comprehensive searches across multiple databases
- Use of Boolean logic, MeSH terms, and thesauri to maximize precision
- Screening, full-text analysis, and data extraction using validated tools
- PRISMA documentation and quality appraisal of included studies
What truly sets NAMSA apart is the depth of our experience and the strength of our regulatory relationships. We have supported a wide range of clients through complex MDR remediation projects, and our EU Regulatory and Medical Writing teams bring firsthand experience working with notified bodies. This insight allows us to anticipate expectations and incorporate real-world feedback directly into our processes. Over time, we’ve refined our templates and methodologies to reflect the evolving regulatory landscape, making our deliverables not only compliant but also highly effective. This combination of expertise, regulatory insight, and proven methodology makes NAMSA the trusted partner for systematic literature reviews in the medical device industry.
Clinical Evidence for Clinical Studies
Robust clinical evidence is the cornerstone of successful clinical study design and regulatory approval. At NAMSA, we help medical device manufacturers generate and strengthen this evidence through expertly conducted literature searches. Whether you’re designing a new clinical investigation or preparing for regulatory submission, our literature search services provide the scientific foundation you need to justify your study design, define performance goals, and benchmark against existing technologies.
Our approach ensures that you identify all relevant published data- favorable and unfavorable- related to your device, target population, and intended use. This includes safety outcomes, adverse event rates, comparator technologies, and standard-of-care practices.
NAMSA’s Literature Search Services support clinical studies by:
- Identifying safety and performance data to inform study design
- Establishing the state-of-the-art for new or evolving technologies
- Supporting sample size calculations with published evidence
- Benchmarking against similar devices or procedures
What makes NAMSA uniquely effective is our ability to combine methodological rigor with deep clinical insight. We work alongside clinical and biostatistics experts who help interpret findings and ensure the evidence is not only comprehensive but also relevant and actionable. When needed, we can involve practicing clinicians to review the literature outputs and provide feedback from a real-world perspective, adding another layer of confidence to your study planning.
With NAMSA, your clinical study is grounded in high-quality, regulatory-ready evidence that supports smarter decisions and faster progress.
Take the Next Step
Want to learn more about our experience in Literature Search? Wondering how long it will take, how we approach it and how much it will cost?
Meet Our Clinical and Regulatory Experts
Explore the depth of our team’s expertise.
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Aurélie San Juan, MSc, PhD
Principal Medical Writer, RegulatoryView Bio -
Kevin Butcher
Principal Regulatory ConsultantView Bio -
Caroline Guidicelli, MSc, MEng
Principal Medical WriterView Bio -
Matt Royle, PhD
Principal Regulatory ConsultantView Bio -
Wendy Schroeder, BSN, CCRC/PM, CRCP
Principal Strategy Consultant, ClinicalView Bio -
Chris Mullin, MS
Director, Global Strategy ServicesView Bio
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Frequently Asked Questions (FAQ) About Literature Search
Do I need a separate literature search for each regulatory deliverable (CER, PMCF, PER, etc.)?
Not necessarily. A single, well-designed literature search can often support multiple regulatory needs—such as Clinical Evaluation Reports (CER) and Post-Market Clinical Follow-up (PMCF); as long as it meets the specific requirements of each. However, the search must be recent and comprehensive enough to remain valid across those uses.
How often should literature searches be updated?
Literature searches should be updated regularly—typically every 1 to 2 years—or whenever there is a significant change in the device, its intended use, or the regulatory landscape. For PMCF and CER updates, the interval between the last search and the report submission should be short enough to ensure relevance, often no more than 6 months.
What makes a literature search “systematic” and why does it matter?
A systematic literature search follows a predefined, transparent methodology that includes a clear research question (for example, the PICO framework), defined inclusion/exclusion criteria, and documented search strategies. This approach minimizes bias and ensures reproducibility—key requirements for regulatory acceptance under MDR, IVDR, and FDA pathways.
How can literature search results support clinical study design?
Literature searches provide clinical outcomes data on performance and safety , adverse event rates, obtained from the same or from comparator technologies. This evidence helps define study endpoints, justify sample sizes, and benchmark performance goals. It also supports regulatory submissions by demonstrating alignment with the current state-of-the-art.
