Systematic Literature Reviews Services
Expertly Written. Regulatory Ready.
PRISMA-aligned systematic and targeted literature reviews that support global regulatory needs while also helping teams answer scientific questions, understand the evidence and competitive landscape, and make informed decisions across the product lifecycle. Reviews may include state-of-the-art, scientific validity, subject device, safety, performance, and customized evidence assessments, with searches led by credentialed medical librarians and conducted under documented quality SOPs for defensible, traceable results.
Frameworks served: EU MDR · EU IVDR · MEDDEV 2.7/1 Rev.4 · MDCG 2020-13
Reporting Standards Applied: PRISMA 2020 · Cochrane Handbook · GRADE · ROBINS-I · AMSTAR-2
650+
Systematic Literature Reviews completed
PRISMA 2020
Reporting standard applied as default
10+ years
Specialized regulatory writing since 2016
100%
Focused on regulatory & medical writing
99%
On-time client submission rate
One systematic review, many downstream deliverables.
A well-scoped SLR is rarely a one-time deliverable. The same protocol, search strategy, and screening pipeline can feed multiple regulatory deliverables across the device or product lifecycle, with appropriate adaptation per framework.
Don’t see the deliverable your SLR needs to support? Contact us and engage with our medical librarians.
Clinical Evaluation Report (CER)
Audience: EU Notified Body
Framework: EU MDR Annex XIV
- State-of-the-Art (SOTA) review
- Subject device clinical evidence retrieval
- Equivalent device data search
- Comparator and alternative therapy review
- Safety signal literature scan
Performance Evaluation Report (PER)
Audience: EU Notified Body
Framework: EU IVDR Annex XIII
- Scientific Validity Report (SVR) literature review
- State-of-the-Art (SOTA) review
- Analytical performance comparator searches
- Clinical performance evidence retrieval
- Alternative IVD benchmark studies
Clinical Study Report (CSR)
Audience: Regulatory Authority
Framework: ICH E3, pharma
- Disease background & epidemiology section
- Standard-of-care benchmark literature
- Benefit-risk literature context
- Adverse event & safety literature
- Background for Module 2.5 / 2.7 summaries
CTD Module 2 Clinical Overview
Audience: Regulatory Authority
Framework: ICH M4
- Disease background & epidemiology
- Standard of care benchmarking
- Clinical pharmacology context
- Comparator efficacy & safety
- Unmet medical need positioning
Scientific Validity Report (SVR)
Audience: EU Notified Body
Framework: EU IVDR
- Analyte / biomarker validity literature
- Clinical association evidence retrieval
- Body of evidence appraisal & synthesis
- SOTA alignment for SVR context
- Ongoing literature surveillance aligned with PMS cycles (when required)
PMCF / PMPF Evaluation Reports
Audience: Post-market / Surveillance
Framework: Post-market
- Annual surveillance literature reviews
- Emerging safety signal scans
- Real-world evidence updates
- New comparator device monitoring
- SOTA refresh on annual update cycles
PSUR / PBRER / DSUR
Audience: Post-market / Surveillance
Framework: ICH E2C(R2), E2F
- Periodic safety literature surveillance
- Benefit-risk literature updates
- Signal detection literature scans
- Targeted indication updates
- Comparative safety profile reviews
FDA 510(k) / De Novo / PMA
Audience: Regulatory Authority
Framework: FDA Medical Device
- Predicate device performance data
- Substantial equivalence support
- Clinical context & standard of care
- Bench testing benchmark literature
- Adverse event & safety literature
State-of-the-Art (SOTA) Reviews
Audience: EU Notified Body
Framework: MDR / IVDR
- Generally acknowledged state of the art
- Currently used and alternative therapies
- Acceptance criteria foundation
- Risk-benefit context
- Standalone SOTA or embedded in CER / PER
Health Technology Assessment
Audience: HEOR / Commercial
Framework: Payer / HTA
- Comparative effectiveness reviews
- Cost-effectiveness literature
- Burden of illness analyses
- Real-world outcomes evidence
- Patient-reported outcome (PRO) reviews
Risk Management Documentation
Audience: EU Notified Body
Framework: ISO 14971
- Hazard identification literature
- Residual risk / SOTA context
- Risk-benefit literature for MDR / IVDR
- Adverse event & complication scans
- Use error & human factors literature
Publication & Scientific Communication
Audience: HEOR / Commercial
Framework: Peer-reviewed
- Manuscript-supporting evidence reviews
- Conference abstract literature scans
- White paper background reviews
- Indirect treatment comparison support
- Periodic update searches for ongoing publication
Need an SLR for a deliverable that isn’t listed? Most of our work is custom-scoped, tell us what the search needs to support.
Every Literature Review Deliverable, Structured for the audit
Our credentialed medical librarians and writers deliver complete PRISMA-aligned systematic literature work for global regulatory submissions, from initial scoping through final synthesis. Criterion Edge provides the methodology rigor, dual-reviewer screening, structured appraisal, and audit trail crucial for documents that meet notified body and FDA regulatory requirements.
Strategy & Search Setup
- Search Strategy & Protocol Authoring
- PICO Question Framing
- Database & Source Selection
- PRISMA 2020 Methodology Documentation
- Inclusion/Exclusion Criteria Development
- Literature Review Protocol
- Search Reproducibility Documentation
- Notified Body Methodology Briefs
Screening & Appraisal
- Title/Abstract Screening (Level 1)
- Full-Text Screening (Level 2)
- Dual-Reviewer Independent Concordance
- Conflict Resolution & Adjudication
- Data Extraction Tables
- Quality Appraisal of Included Studies
- Risk of Bias Assessment
- PRISMA Flow Diagram Generation
Synthesis & Deliverables
- State of the Art Reports (SOTA)
- Clinical Evaluation Reports (CERs) and Performance Evaluation Reports (PERs)
- Scientific Validity Reports (SVR)
- IVDR Performance Reports (APR, CPR)
- Surveillance Literature Reviews
- Equivalence & Comparator Justifications
- Evidence Synthesis & Narrative Reporting
- Executive Summaries for SMEs
- Searches Aligned with PMS Reporting Requirements
A well-scoped SLR can feed multiple regulatory deliverables. Tell us your downstream needs, we’ll structure the search to gain efficiencies.
Document Your Methodology from Day One
This section is a quick orientation to the PRISMA 2020-aligned workflow our credentialed medical librarians follow on every regulatory SLR engagement.
Protocol-first methodology
Every regulatory SLR starts with a written protocol that defines the research question (PICO/PICOS framing), inclusion/exclusion criteria, database panel, search strategy, screening procedure, data extraction fields, appraisal tool, and synthesis approach. The protocol is signed off before any searches run, so reviewers see a pre-specified methodology rather than retrospective rationalization.
Database panel matched to the question, not convenience
PubMed/MEDLINE is necessary but not always sufficient. Embase coverage of European clinical literature is materially different. For some indications, Cochrane Database, Scopus, Web of Science, and grey literature (conference proceedings, registry data, regulator guidance) may also be essential. We use professional database platforms, and we document the database, platform, and search-date combination explicitly so the search is reproducible.
Dual-reviewer screening with documented adjudication
Single-reviewer screening introduces selection bias and is increasingly flagged by notified bodies. Our default is two independent reviewers at title/abstract and full-text screening, with conflicts adjudicated by a senior reviewer. The adjudication log is part of the audit trail, not a separate file.
Structured critical appraisal
We apply the appropriate appraisal and analysis criteria to ensure the suitability and quality of the data contributing to the regulatory submission. The chosen tool, GRADE, ROBINS-I, AMSTAR-2, RoB 2, JBI, or another, is documented in the protocol, not chosen post-hoc to fit the data.
A literature review methodology that meets regulatory standards
Our SLR process follows PRISMA 2020 reporting standards from start to finish, with documented decisions, dual-reviewer screening, and a complete audit trail at every step.
Define & Scope
Frame the research question, define inclusion/exclusion criteria, plan your choice of databases, and design the protocol. Every project starts with a protocol signed off before any searches run.
- Frame the research question (PICO / PICOS)
- Define inclusion / exclusion criteria
- Plan your choice of databases
- Design the protocol & ownership matrix
Search & Capture
Execute the pre-specified search across PubMed/MEDLINE, Embase, Cochrane, and indication appropriate databases. Capture grey literature, registries, and regulator guidance where applicable, deduplicate, and log every database, platform, and date combination.
- Document search syntax per database
- Date stamp every search & record reproducibility notes
- Capture grey literature where applicable
- Capture grey literature where applicable
Screen & Appraise
Two independent reviewers at title/abstract and full-text screening, with conflicts adjudicated by a senior reviewer. Apply the protocol-defined appraisal tool and document the rationale, not just the score.
- Dual-reviewer Level 1 screening (title / abstract)
- Dual-reviewer Level 2 screening (full text)
- Conflict adjudication with audit log
- Critical appraisal using the protocol-defined tool
Synthesize & Report
- Structured data extraction & evidence tables
- Narrative synthesis and reporting of meta-analysis results where appropriate
- PRISMA 2020 flow diagram & reporting checklist
- Feed synthesis forward into CER / PER / CSR / Module 2 deliverables
Databases and Information Sources
PubMed/MEDLINE, Embase, Cochrane Library, Scopus, Web of Science, ClinicalTrials.gov, WHO ICTRP, regulatory databases, grey literature sources, conference proceedings, and other relevant scientific or industry sources as appropriate.
Specialist Writers, not Generalists
Criterion Edge is led by an experienced team of regulatory and medical writing professionals across IVD, Medical Device, and Pharmaceutical specialties. Each director brings direct, hands-on industry experience, not just regulatory awareness, backed by a wider bench of credentialed medical librarians and specialty writers.
Laurie Mitchell, MSN
President & Founder
Founded Criterion Edge in 2016 to build a specialist regulatory writing firm. Sets methodology, quality standards, and writer development across the IVD, Medical Device, and Pharma/Biologics teams.
Stephanie Knighten
Senior Director of Medical Device Writing Services
Twenty-one years of experience across medical device, nonclinical, and clinical regulatory writing. Specializes in EU MDR strategy and MEDDEV guideline compliance. Proven leader of medical writing teams delivering compliant submissions for medical device and pharmaceutical clients alike.
Sarah Chavez, PhD
Director, IVD & Scientific Writing Services
Director of IVD and Scientific Writing Services since 2022, originally joining Criterion Edge as Principal Medical Writer in 2018. PhD in Molecular and Cellular Biology. Brings twenty years of benchtop molecular biology experience and a teaching background in genetics, biochemistry, and biology to IVDR-ready technical documentation.
Emily Garcia, PhD
Director of Pharmaceutical Writing
Emily brings 18 years of pharmaceutical and medical device experience, specializing in clear, high-quality clinical and regulatory documents. She has led writing teams, improved processes, and supported organizations of all sizes throughout the product lifecycle.
Extended Team
Medical Librarians & Specialist Writers
A wider bench of credentialed medical librarians, scientific writers, and contract specialists scaled to your timeline. Same QC standards across every project — full team introductions during scoping.
The Criterion Edge Differentiators
Regulatory and medical writing is the only thing we do. That focus shows up in how we staff projects, how we manage timelines, and how we handle the work that other teams treat as overhead.
Credentialed medical librarians, not generalists
How we work: Our search strategies are designed by credentialed medical librarians, MLS / MLIS / PhD-level professionals who do this every day. Database selection, syntax design, grey-literature scoping, and search-strategy peer review are run by specialists, not by clinical writers who happen to know PubMed.
Common to large CROs: Literature searches are often run by clinical writers or junior team members, with database choices driven by what’s familiar rather than what fits the question.
Common to large CROs: Literature searches are often run by clinical writers or junior team members, with database choices driven by what’s familiar rather than what fits the question.
Dual-reviewer screening by default
How we work: Two independent reviewers screen every title/abstract and full-text record, with conflicts adjudicated by a senior reviewer and the adjudication log kept as part of the deliverable. Notified bodies increasingly flag single-reviewer screening as introducing selection bias, our default makes that question moot.
Common to large CROs: Single-reviewer screening is still common, with dual screening offered as a paid add-on rather than the default.
Common to large CROs: Single-reviewer screening is still common, with dual screening offered as a paid add-on rather than the default.
Database panels matched to the question, not convenience
How we work: PubMed/MEDLINE is necessary but not always sufficient. Embase coverage of European clinical literature is materially different. Cochrane Database, Scopus, Web of Science, and grey literature (conference proceedings, registry data, regulator guidance) are added where the question warrants. We use professional database platforms and document the database, platform, and search-date combination explicitly.
Common to large CROs: PubMed-only searches are still surprisingly common, even for MDR / IVDR submissions where Embase coverage materially changes the result set.
Common to large CROs: PubMed-only searches are still surprisingly common, even for MDR / IVDR submissions where Embase coverage materially changes the result set.
Search dates kept current through surveillance cycles
How we work: One of the most common notified body deficiencies is a CER or PER citing literature searches more than 12 months out of date at submission. We document search dates explicitly, build update protocols into the original methodology, and offer annual surveillance review cycles for PMCF/PMPF, PSUR/PBRER, and living SOTA refresh, so the search stays current when the audit lands.
Common to large CROs: Search updates are often quoted as separate projects rather than built into the methodology, leaving sponsors to re-engage on every cycle.
Common to large CROs: Search updates are often quoted as separate projects rather than built into the methodology, leaving sponsors to re-engage on every cycle.
PRISMA 2020 reporting as default
How we work: Every regulatory SLR is reported against the PRISMA 2020 checklist, with a PRISMA flow diagram, PRISMA-S search disclosure, and reporting checklist included as standard deliverables. Appraisal tools (GRADE, ROBINS-I, AMSTAR-2, Cochrane RoB 2, JBI) are selected in the protocol and documented in the report, not chosen post-hoc.
Common to large CROs: PRISMA reporting is inconsistently applied, often only the flow diagram is included, with the rest of the checklist treated as optional.
Common to large CROs: PRISMA reporting is inconsistently applied, often only the flow diagram is included, with the rest of the checklist treated as optional.
Stable team from kickoff to delivery
How we work: The librarian who designs the search runs the search. The reviewers who screen also extract. The writer who synthesizes is part of the original kickoff team. That continuity matters when a deficiency letter asks why a specific database was excluded, the person who made that decision is still on the project.
Common to large CROs: Searches, screening, and writing are often handled by different teams in different rotations, so deficiency responses require re-orientation to the file.
Common to large CROs: Searches, screening, and writing are often handled by different teams in different rotations, so deficiency responses require re-orientation to the file.
Regulatory and medical writing is all we do
How we work: Literature work, regulatory writing, and clinical writing is the firm, not one offering inside a hundred. Our methodology, QC framework, and librarian training exist because this work is the entire business, not because someone needed to fill a billable hour.
Common to large CROs: Medical writing and literature search are services inside a broader business that prioritizes clinical operations, biostatistics, and data management.
Common to large CROs: Medical writing and literature search are services inside a broader business that prioritizes clinical operations, biostatistics, and data management.
Quoted from Post-Project Surveys
Survey Responses
Below are the average scores (out of 5) for each of the criteria we ask our clients to grade us on after every project.
/ 5.00
Where our SLR-backed documentation has reached
Our PRISMA-aligned literature work supports global regulatory submissions:
FDA SLR & literature review services
PRISMA-aligned literature reviews supporting FDA submissions, 510(k) substantial equivalence packages, De Novo classification requests, PMA clinical literature sections, NDA Module 2.5 clinical overviews, and 505(b)(2) literature-based pathways. Our credentialed medical librarians design search strategies that capture the evidence FDA reviewers expect to see, including grey literature, conference proceedings, and registry data when appropriate. Dual-reviewer screening and structured appraisal are the default, so the methodology holds up under FDA review.
EU MDR & IVDR literature review services
State-of-the-Art (SOTA) reviews, Scientific Validity Reports (SVR), and clinical evidence searches underpinning MDR Clinical Evaluation Reports and IVDR Performance Evaluation Reports. Methodology aligned with MEDDEV 2.7/1 Rev.4, MDCG 2020-13, and MDCG 2022-2. Our SLRs have supported submissions reviewed by BSI, TÜV SÜD, DEKRA, GMED, and TÜV Rheinland, with the audit trail, two-reviewer screening, and updated search dates that notified bodies expect to see at first review. State-of-the-Art (SOTA) reviews, Scientific Validity Reports (SVR), and clinical evidence searches underpinning MDR Clinical Evaluation Reports and IVDR Performance Evaluation Reports. Methodology aligned with MEDDEV 2.7/1 Rev.4, MDCG 2020-13, and MDCG 2022-2. Our SLRs have supported submissions reviewed by BSI, TÜV SÜD, DEKRA, GMED, and TÜV Rheinland, with the audit trail, two-reviewer screening, and updated search dates that notified bodies expect to see at first review.
SOTA is foundational. Everything else in the submission references it.
An outdated literature search, missing alternative-device benchmark, or thin justification for clinical equivalence weakens the entire submission. Notified bodies under MDR and IVDR have published common deficiency themes; nearly all of them point back to systematic literature methodology that wasn’t systematic. We treat literature work as the regulatory deliverable it actually is, reproducible, two-reviewer, PRISMA-aligned, with a complete audit trail. Not a narrative summary that happens to cite some papers.
Search dates older than 12 months
One of the most common notified body deficiencies: a CER or PER citing literature searches more than 12 months out of date at the time of submission. We document search dates explicitly, build update protocols into the original methodology, and offer annual surveillance review cycles to keep deliverables current.
Don’t stop at PubMed
Database coverage is a frequent deficiency theme. PubMed/MEDLINE is necessary but not always sufficient. Embase coverage of European clinical literature is materially different, and for some indications, Cochrane, Scopus, and grey literature may also be essential. We design database panels appropriate to the question, not the writer’s convenience.
Single-reviewer screening doesn’t hold up
Notified bodies increasingly question single-reviewer screening as introducing selection bias. Dualreviewer with documented adjudication is the defensible standard. We apply it as default for regulatory SLRs, and the audit trail makes it visible to reviewers without them having to ask.
Frequently Asked Questions
What is a systematic literature review and why do regulators require one?
A systematic literature review (SLR) is a structured, reproducible search of published evidence to answer a defined clinical or regulatory question. SLRs follow PRISMA 2020 reporting standards: a documented search strategy across multiple databases, defined inclusion/exclusion criteria, twolevel screening, quality appraisal of included studies, and synthesis of results with a complete audit trail. Regulators require systematic literature work because narrative reviews can selectively cite favorable evidence; SLR methodology forces transparency and reproducibility.
What is PRISMA 2020 and is it required for regulatory submissions?
PRISMA 2020 (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) is the updated reporting standard for systematic reviews, published in 2021. It defines a 27-item checklist and a flow diagram showing study selection at each stage. While PRISMA itself is a reporting standard rather than a regulation, notified bodies under MDR and IVDR explicitly expect PRISMAaligned literature work, and MDCG 2020-13 references PRISMA principles. Submissions that fail to meet its rigor are commonly cited in deficiency letters. PRISMA 2020 (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) is the updated reporting standard for systematic reviews, published in 2021. It defines a 27-item checklist and a flow diagram showing study selection at each stage. While PRISMA itself is a reporting standard rather than a regulation, notified bodies under MDR and IVDR explicitly expect PRISMAaligned literature work, and MDCG 2020-13 references PRISMA principles. Submissions that fail to meet its rigor are commonly cited in deficiency letters.
What is the difference between a State of the Art (SOTA) review and a Scientific Validity (SVR) review?
A State of the Art (SOTA) review establishes the current accepted clinical practice, available alternative devices or therapies, and benchmark performance characteristics for a target condition. It provides the comparative context against which the subject device’s performance is evaluated. A Scientific Validity Report (SVR), specific to IVDs under IVDR Annex XIII, demonstrates the association between an analyte and a clinical condition or physiological state. Both rely on systematic literature methodology but answer different questions; CERs typically need SOTA, PERs need both.
How long does a systematic literature review take?
Scoping the search strategy and protocol typically takes 1 week. Database searches and deduplication are usually complete within days. The longest portion is screening, ranging from 1–4 weeks depending on volume of returned records. Quality appraisal, data extraction, and synthesis writing typically take an additional 2-5 weeks. Total end-to-end timeline ranges from 4 to 10 weeks for a focused review and longer for broad SOTA work.
Which databases does Criterion Edge search?
We routinely search PubMed/MEDLINE, Embase, the Cochrane Library, and ClinicalTrials.gov as core sources. Depending on scope and regulatory framework, we extend to Scopus, Web of Science, FDA Access, GUDID, MAUDE, EUDAMED (where applicable), regulatory grey literature, conference proceedings, and disease-specific specialty databases. Search strategies are documented per PRISMA 2020 with full syntax, dates, and reproducibility notes.
What is dual-reviewer screening and why does it matter?
Dual-reviewer screening means two independent reviewers assess each record against the inclusion/exclusion criteria, with disagreements resolved by consensus or a third reviewer. This is the gold-standard practice in systematic reviews because single-reviewer screening introduces selection bias and is rarely defensible to regulators. Notified bodies increasingly question singlereviewer approaches in CER and PER literature work. Criterion Edge applies dual-reviewer screening as standard for regulatory SLRs.
What is a Living Literature Review and do you offer one?
A Living Literature Review is a continuously updated SLR, with periodic surveillance searches and incremental incorporation of new evidence. Under MDR and IVDR, the post-market literature surveillance feeding CER/PER updates and PMCF/PMPF reporting is essentially a living review. Criterion Edge provides annual surveillance literature reviews configured to feed directly into CER, PER, and PSUR update cycles, maintaining the original PRISMA audit trail across versions.
Why do notified bodies issue deficiencies on literature review work?
Common deficiency themes include: outdated search dates (more than ~12 months old), narrow database coverage (PubMed alone), unjustified exclusion of relevant studies, missing alternative-device or comparator coverage, single-reviewer screening, narrative summary instead of structured appraisal, and absence of a PRISMA flow diagram or reproducible search strategy. Treating literature work as systematic review rather than narrative summary addresses most of these upfront.
Can the same SLR feed multiple deliverables?
Yes, and structuring it that way is a core best practice. A well-scoped SLR can support multiple regulatory deliverables: SOTA sections within a CER or PER, scientific validity demonstration, clinical equivalence justification, post-market surveillance updates, and clinical overviews in CTD Module 2. We structure literature work to maximize this reuse, with extracted data tables and appraisal results designed for reuse across deliverables while respecting the documentation conventions each requires.
Go deeper on SLR methodology, PRISMA reporting, and regulatory literature work.
Selected guides, white papers, and webinars from the Criterion Edge team on systematic literature review methodology for regulatory submissions, scientific communication, and HEOR.
Designing an SLR That Serves Both Regulatory & Commercial Goals
Guide
A methodology-forward look at systematic literature reviews that work for both regulatory submission and HEOR/payer evidence. Useful for sponsors planning a single SLR to support multiple downstream deliverables.
Conducting SLRs in Support of IVDR Readiness
Guide
A practical breakdown of the SLR process specifically for IVDR Performance Evaluation Reports and Scientific Validity Reports. Tools, best practices, and a wholistic approach to IVD literature work.
Building Methodologically-Sound SLRs
Webinar Series
Recorded webinars from Laurie Mitchell and the Criterion Edge team on PRISMA workflow, dualreviewer screening, search strategy design, and critical appraisal for regulatory literature work.
SLRs Across the Pharma Documentation Lifecycle
Guide
How SLRs feed background literature for Module 2.5 / 2.7 summaries, CSRs, PSURs / PBRERs, and the broader documentation lifecycle from pre-clinical through submission and post-marketing.
Regulatory and Clinical Writing Across Modalities
Original guides and on-demand webinars from our medical device writing team, drawn from decades of MDR-compliant CER experience.
IVDR & FDA in vitro diagnostics writing
Performance Evaluation Reports, Scientific Validity Reports, Clinical Performance Reports, Analytical Performance Reports, and full IVDR Annex XIII technical documentation. 100+ PERs accepted by EU notified bodies including BSI, TÜV SÜD, GMED, and DEKRA.
Evidence Base: Systematic literature reviews
PRISMA-compliant systematic literature reviews authored by credentialed medical librarians, state of the art reviews, equivalence reviews, and surveillance literature that underpins CERs, PERs, and notified body submissions.
Pharmaceutical regulatory writing
ICH-compliant clinical and regulatory writing for pharmaceutical and biologics submissions across FDA, EMA, MHRA, Health Canada, PMDA and other ICH-region authorities.
Have a literature review need? Let's scope it.
- No obligation, just an open conversation
- Direct guidance from credentialed medical librarians
- Trusted by leading IVD, MedTech & Pharma companies
- Flexible turnaround for time-sensitive submissions
- Clear scoped quotes, no budget surprises
- One business day response window
