Medical Device Writing Services
Across Every Submission
Expertly Written. Regulatory Ready.
From early evidence generation through regulatory submission and post-market documentation, Criterion Edge delivers PhD-level medical report writing for the medical device, pharmaceutical, and diagnostics industries. One partner for every document, built to support compliance, withstand regulatory review, and move your program forward.
Not ready to submit yet? Talk with one of our medical writing experts at no cost to learn what typically slows submissions down, what timelines to expect.
100
CERS AND 510(k)s Authored
650
Systematic Literature reviews completed
10 years
Specialized regulatory writing since 2016
Medical Device Regulatory and clinical writing services
Every Medical Device document on your submission checklist.
Medical device submissions rarely consist of a single document. Criterion Edge supports the complete regulatory documentation package from clinical evaluation and FDA submissions to technical documentation and global market support providing experienced writers, scalable resources, and a quality-controlled process from project kickoff through submission.
EU MDR Clinical Documentation
- Clinical Evaluation Plans (CEP)
- Clinical Evaluation Reports (CER)
- Clinical Development Plans
- Literature Search Reports
- Postmarket Clinical Follow-up (PMCF) Plans
- PMCF Evaluation Reports
- Periodic Safety Update Reports (PSUR)
- Summary of Safety & Clinical Performance (SSCP)
- GSPR Conformity Documentation
- Notified Body Deficiency Responses
U.S. Regulatory Submissions
- 510(k) Premarket Notifications
- De Novo Classification Requests
- Premarket Approval Applications (PMA)
- Investigational Device Exemptions (IDE)
- Predicate Device Comparison Tables
- Substantial Equivalence Discussions
- FDA Q-Submission Authoring
- Indications for Use Statements
Technical Documentation
- Technical File Authoring
- Risk Management Documentation (ISO 14971)
- Instructions for Use (IFU)
- Labeling Review & Authoring
- Design History File (DHF) Support
- Regulatory Document Gap Analyses
- Template Review & Development
- Equivalence Justifications
Supporting medical device submissions beyond the U.S. and European Union.
Criterion Edge supports medical device regulatory submissions and supporting documentation for health authorities around the world. Whether preparing a new market application, responding to regulatory questions, or updating existing documentation, our writers adapt content to the expectations of each regulatory framework while maintaining consistency across global submissions.
Health Canada
- Medical Device Licence (MDL) applications
- Class II, III, and IV device submissions
- Licence amendments and post-market updates
- Clinical evidence summaries and supporting documentation
United Kingdom (MHRA)
- UKCA technical documentation support
- UK Clinical Evaluation Reports (CER)
- UK PMS and PMCF documentation
- Regulatory response support
Australia (TGA)
- Australian Register of Therapeutic Goods (ARTG) supporting documentation
- Clinical evidence packages
- Technical documentation alignment
- Regulatory submission support
A methodology built for documents that get audited.
Our medical device writing process is documented and quality-controlled from scope through delivery. Quality control is not a final step; it runs through every stage.
Scope & Plan
Define the document set, confirm the device classification and intended purpose, identify the applicable framework and current guidance, and agree on the clinical evaluation plan. Every project begins with a written scope and a clear division of responsibilities.
- Define the document set and scope
- Confirm classification and intended purpose
- Identify applicable MDR articles and MDCG guidance
- Inventory source data and references
Search & Appraise
Conduct the systematic literature search to a documented, PRISMA-compliant protocol, with dual-reviewer screening and critical appraisal. Establish and document the current state of the art against current clinical practice, benchmark devices, and alternative treatments.
- Design the systematic literature review protocol aligned with PRISMA reporting principles
- Dual-reviewer screening & critical appraisal
- Establish the state of the art
- Assemble & document the clinical data set
Author & Quality Control
Draft each document to the applicable templates and current guidance, ensuring consistency across the CER, CEP, PMCF, PSUR, and SSCP (if applicable). Quality control is applied at every milestone, with an independent QC review before delivery.
- Draft to applicable templates & guidance
- Reconcile cross-document consistency
- Apply quality control at every milestone
- Independent QC review before delivery
Deliver & Support
Deliver submission-ready documentation and support notified body deficiency responses on the clinical documentation. As clinical evaluation continues across the lifecycle, documents are updated when new clinical data, PMCF results, or revised guidance require it.
- Deliver submission-ready documentation
- Support notified body deficiency responses
- Update documents as PMCF data accrues
- Revise to reflect updated guidance
Clinical evaluation is a continuous process, not a one-time deliverable. Steps 2 through 4 repeat across the device lifecycle as new clinical data, PMCF results, and updated guidance require revised documentation.
Therapeutic areas where our writing has reached submission.
Criterion Edge has authored regulatory and clinical documentation across the breadth of risk classifications and therapeutic areas, from Class I devices through Class III active implantables, including combination products.
This is a select list, not comprehensive. Don’t see your therapeutic area? Contact us and engage with our device experts → We’ve likely worked on it.
Risk legend: I Low risk · IIa Moderate · IIb Medium-High · III Highest
Cardiovascular & Vascular
MDR Class IIb–III / FDA Class II–III)
- Cardiac stents & vascular grafts
- Pacemakers & ICDs
- Heart valves & annuloplasty rings
- Catheters & guidewires
- Cardiopulmonary bypass devices
Orthopedic & Spinal
MDR Class IIb–III / FDA Class II–III
- Joint replacement implants
- Spinal fusion systems
- Trauma plates & screws
- Bone substitutes & scaffolds
- External fixation systems
Surgical & Interventional
MDR Class IIa–III / FDA Class II)
- Energy-based devices (RF, ultrasonic)
- Surgical staplers & suturing
- Endoscopes & visualization
- Robotic surgical systems
- Hemostasis & sealing products
Software as a Medical Device
MDR Class IIa–III / FDA Class II
- AI/ML diagnostic algorithms
- Clinical decision support
- Imaging post-processing
- Remote monitoring platforms
- Mobile medical applications
Mobile medical applications
MDR Class III / FDA Class III)
- Drug-eluting stents
- Pre-filled syringes & auto-injectors
- Inhalers & nebulizers
- Drug-coated balloons
- Antimicrobial-coated devices
Diagnostic Imaging Equipment
MDR Class IIa–IIb / FDA Class II
- MRI & CT systems
- Ultrasound & echocardiography
- X-ray & fluoroscopy
- Nuclear medicine systems
- Imaging contrast accessories
Wound Care & Tissue Repair
MDR Class IIa–III / FDA Class II–III)
- Advanced wound dressings
- Negative pressure wound therapy
- Surgical meshes & matrices
- Tissue scaffolds
- Skin substitutes
Ophthalmic Devices
MDR Class IIa–III / FDA Class II–III
- Intraocular lenses (IOLs)
- Contact lenses
- Refractive surgery devices
- Glaucoma drainage devices
- Ophthalmic surgical instruments
Neurology & Neuromodulation
MDR Class III / FDA Class III)
- Deep brain stimulators (DBS)
- Spinal cord stimulators
- Vagal nerve stimulators
- Neurosurgical implants
- Cerebrospinal fluid shunts
ENT & Audiology
MDR Class IIa–III / FDA Class II–III
- Cochlear implants
- Hearing aids & bone conduction
- Middle ear prosthetics
- Sleep apnea / OSA devices
- Sinus stents & balloons
Urology & Gynecology
MDR Class IIa–III / FDA Class II–III
- Pelvic floor & transvaginal mesh
- Urinary catheters & stents
- IUDs & contraceptive devices
- Endometrial ablation systems
- Penile / continence implants
Dental & Maxillofacial
MDR Class IIa–III / FDA Class II
- Dental implants & abutments
- Orthodontic devices
- Restorative materials
- Maxillofacial reconstruction
- Bone grafting materials
Typical MDR risk class shown per Annex VIII and MDCG 2021-24. Examples are illustrative; a given device’s class depends on its intended purpose and configuration. We confirm the exact rule and class for your device during scoping.
Don’t see your therapeutic area? We’ve likely worked on it, ask us about your device.
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 specialist writers.
Laurie Mitchell, MN
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
Director, Medical Device
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.
Lead authors with MDR-specific experience
How we work: Your project is staffed by writers who have already authored Clinical Evaluation Reports, PMCF Plans and Evaluation Reports, PSURs, and Technical Documentation under MDR, not generalists learning the framework on your timeline.
Common to large CROs: Annex XIV responsibilities are often delegated to junior writers or staff cycling through medical writing on rotation.
Common to large CROs: Annex XIV responsibilities are often delegated to junior writers or staff cycling through medical writing on rotation.
Documentation that has been through notified body review
How we work: Our writing has supported submissions reviewed by BSI, TÜV SÜD, DEKRA, TÜV Rheinland, SGS, DNV, and others. Reviewers have seen our work and their queries shape how we structure the next file.
Common to large CROs: Teams are often assigned with little or no experience of the specific notified body reviewing the file.
Common to large CROs: Teams are often assigned with little or no experience of the specific notified body reviewing the file.
Credentialed medical librarians for literature work
How we work: State of the art reviews and clinical evidence searches are conducted systematically, not as narrative summaries. Criterion Edge uses PRISMA-compliant search strategies, dual-reviewer screening, and structured appraisal, the methodology a notified body expects to see.
Common to large CROs: Literature reviews are often written non-systematically, without a credentialed librarian running the search strategy.
Common to large CROs: Literature reviews are often written non-systematically, without a credentialed librarian running the search strategy.
Staffing scaled to your deadline
How we work: Submission timelines move. We adjust team size to match, without forcing your project into a fixed slot or queue. Your writers are committed to your project from kickoff to submission.
Common to large CROs: Projects are slot-based and queue-bound. Acceleration requires escalation, and the original team rarely scales with the work.
Common to large CROs: Projects are slot-based and queue-bound. Acceleration requires escalation, and the original team rarely scales with the work.
Stable team from kickoff to delivery
How we work: The writers introduced at scoping are the writers on your file at submission. Continuity matters when a deficiency response references work done eight months earlier, the person who wrote it is still on the team.
Common to large CROs: Writers rotate between projects, and deficiency responses are often re-staffed to whoever is available, requiring re-orientation to the file.
Common to large CROs: Writers rotate between projects, and deficiency responses are often re-staffed to whoever is available, requiring re-orientation to the file.
Clear scoped quotes with no budget surprises
How we work: Every engagement begins with a written scope and a fixed quote. If scope changes, we tell you before we work. No master service agreements with hidden change orders.
Common to large CROs: Master service agreements with hourly billing and change orders, where the final cost is rarely close to the initial estimate.
Common to large CROs: Master service agreements with hourly billing and change orders, where the final cost is rarely close to the initial estimate.
Regulatory and medical writing is all we do
How we work: Writing is not one offering inside a hundred. It is the firm. Our methodology, QC framework, and writer development exist because this work is the entire business, not because someone needed to fill a billable hour.
Common to large CROs: Medical writing is one capability inside a hundred, competing for internal investment with operations, biostatistics, and clinical management.
Common to large CROs: Medical writing is one capability inside a hundred, competing for internal investment with operations, biostatistics, and clinical management.
What our clients have to say
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
Frequently Asked Questions
What is a Clinical Evaluation Report (CER) under EU MDR?
A Clinical Evaluation Report (CER) is the primary document describing the clinical evaluation required for CE marking of a medical device under Regulation (EU) 2017/745 (MDR). It documents systematic appraisal of clinical data, from clinical investigations, post-market surveillance, and published literature, against the device’s intended purpose and the General Safety and Performance Requirements (GSPR). MDR Annex XIV requires the CER to be updated throughout the device lifecycle and reviewed during conformity assessment.
What is the difference between a CER and a Clinical Evaluation Plan (CEP)?
A Clinical Evaluation Plan (CEP) is the upfront methodology document, it defines scope, equivalence claims, evidence sources, search strategies, and acceptance criteria before the evaluation begins. The CER is the executed evaluation following that plan, including findings, benefit-risk analysis, and conclusions. Both are required under MDR Annex XIV; the CEP is reviewed by notified bodies as evidence of methodological rigor.
What is PMCF and why does MDR require it?
Post-Market Clinical Follow-up (PMCF) is the proactive collection of clinical data on a CEmarked device in real-world use, generally expected for most MDR devices unless appropriately justified. PMCF is the bridge between pre-market clinical evidence and the device’s actual longterm safety and performance. It feeds back into CER updates, PSUR reporting, and ongoing benefit-risk analysis. Notified bodies expect a PMCF Plan up front and a PMCF Evaluation Report at defined intervals.
What is the difference between a 510(k), De Novo, and PMA?
The three FDA pathways differ by device risk and predicate status. A 510(k) demonstrates substantial equivalence to a legally marketed predicate device for Class I and II devices. A De Novo classifies a novel low-to-moderate risk device that has no predicate, creating a new device classification. A PMA (Premarket Approval) is the most rigorous pathway, required for Class III devices, and demands clinical performance data demonstrating reasonable assurance of safety and effectiveness.
How long does it take to write a Clinical Evaluation Report?
Typical timelines for a CER range from approximately 10 to 14 weeks for a Class IIa device with complete source data, and 12 to 16 weeks for a Class III or implantable device requiring extensive systematic literature review. Timeline depends on device complexity, intendedpurpose breadth, equivalence claims, and the depth of post-market data already available. Criterion Edge offers expedited timelines through scaled writer teams.
What is MEDDEV 2.7/1 Rev 4 and is it still applicable under MDR?
MEDDEV 2.7/1 Rev 4 is the legacy European Commission guideline on clinical evaluation, originally written under the MDD. Although MDR is the current legal framework, MEDDEV 2.7/1 Rev 4 remains the most detailed methodological reference for CER structure and content; notified bodies commonly continue to expect its principles to be applied alongside MDCG 2020-13 (the MDR-era guidance on CER assessment).
Which notified bodies has Criterion Edge worked with for MDR submissions?
Criterion Edge has authored documentation for MDR submissions reviewed by major EU notified bodies including BSI, TÜV SÜD, DEKRA, and SGS. Our writers are familiar with the documentation expectations and common review observations of major notified bodies.
Can Criterion Edge handle aggressive submission timelines?
Yes. Criterion Edge maintains a flexible staffing model that scales writer teams to match urgent client timelines, including parallel writing tracks for multi-document submissions and notified body deficiency response turnarounds. Discuss your deadline during scoping and we will structure a delivery plan around it, including bringing on vetted contract writers from our extended network where appropriate.
What is the difference between MDR and the previous Medical Device Directive?
Regulation (EU) 2017/745 (MDR) replaced Directive 93/42/EEC (MDD) and Directive 90/385/EEC (AIMDD) and has applied since 26 May 2021. Following Regulation (EU) 2023/607, transitional periods extend for legacy devices until 31 December 2027 for higher-risk devices and 31 December 2028 for medium- and low-risk devices, subject to conditions. Key changes include: expanded scope to certain non-medical aesthetic products; reclassification of some devices to higher classes; mandatory PMCF for most devices; EUDAMED registration; public SSCP for Class III and implantable devices; and significantly stricter clinical evidence requirements.
Resources and Insights
Go deeper on MDR, CER, and PMCF.
Original guides and on-demand webinars from our medical device writing team, drawn from decades of MDR-compliant CER experience.
How to Assess Your CER for MDR Readiness
Webinar Series
A practical 2-part series for assessing your Clinical Evaluation Report against EU MDR expectations. Covers state of the art, safety and performance criteria, equivalence, systematic literature review, clinical data sources, and risk-benefit analysis.
CER for MDR Readiness
State of the Art, Safety & Performance Criteria, Equivalence, SLR
Webinar Series – Part 1
Strategies for assessing the upstream sections of your CER against MDR requirements, presented from the perspective of seasoned regulatory writers with deep MEDDEV rev. 4 and MDR-compliant CER authorship experience.
CER for MDR Readiness
Clinical Data Sources, Equivalence, Risk/Benefit Analysis
Webinar Series – Part 2
The second installment focuses on the clinical evidence backbone of your CER, including equivalence claims, post-market data integration, and benefit-risk reasoning. Includes a writer’s gap-analysis checklist before submission.
Hidden Traps That Derail PER Preparedness:
Lessons from MDR-Compliant CER Experience
Webinar
What MDR-CER writing teaches us about IVDR-PER preparedness. Identifies the critical inputs, hidden gaps, and mitigation steps that determine whether a Performance Evaluation Report ships on time or stalls in deficiency rounds.
Related Services
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.
In Vitro Diagnostics: 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.
Pharma & Biologics: 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.