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Engineering and Health Technology Writing, Statistics and Documentation

Pubrica supports engineering teams, data science groups and health technology companies with technical writing, statistical analysis and documentation for technologies that make clinical claims. Our work covers algorithms, prediction models, device engineering, sensors and medical device software. We prepare algorithm validation reports, TRIPOD+AI prediction model reporting, technical and engineering papers, health technology evidence and standards documentation, written so both engineering and clinical reviewers can assess them.

Main servicesengineering and health technology

Each claim in a document is linked to the result that supports it.

Every project
  • Assigned by discipline
  • Claims mapped to supporting results
  • Code and parameters delivered
  • Mutual NDA on request
  • You remain the named author

Service Scope

Technical documentation that engineering and clinical reviewers can assess

We write validation reports, performance summaries and papers that state test conditions, comparators and limitations. This helps clinical, regulatory and journal reviewers assess results produced by engineering teams.

Approach

Claims linked to results

Each claim is linked to the result that supports it, so a reviewer can check it directly.

Audience

Your intended reviewer

Documents are written for the specific reader: a notified body, journal reviewer, payer or partner.

Reporting standard

TRIPOD+AI where it applies

Prediction models that make clinical claims are reported using TRIPOD+AI.

Our Services

Writing, analysis and documentation for engineering and technology teams

Available as individual projects or as an ongoing arrangement.

Services and applicable standards

Algorithm validation reportingValidation reports written for both clinical and engineering reviewers
Prediction model reportingReported to TRIPOD+AI, including machine-learned models
Technical and engineering papersPrimary manuscripts for engineering and applied journals
Health technology evidenceDocumentation showing whether a technology improves outcomes, not only measurements
Software documentationDocumentation for medical device software under IEC 62304
Standards and conformity writingDocumentation mapped to the standard being claimed
Statistical analysisStudy design, validation statistics and confidence intervals
Figures and illustrationTechnical diagrams prepared for publication
Grant and funding applicationsIncluding translational and innovation funding
Patent-adjacent writingTechnical descriptions prepared alongside your patent attorney

Who We Serve

Teams we work with

Each scoping read is tailored to the role and needs of the team requesting it.

Who we support

Engineering leadsValidation reports that clinical reviewers can assess
Data science teamsPrediction model reporting in line with TRIPOD+AI
Regulatory affairsDocumentation for technologies becoming regulated devices
Academic engineering groupsPapers, grants and the analysis behind them
Health technology companiesHealth technology evidence on patient outcomes
Product and clinical leadsProduct claims checked against the evidence before use

Standards and Guidelines

Standards we write to

Each deliverable is written to the current edition of the relevant standard. Where a standard has changed recently, the deliverable states which version was used.

Applicable standards

TRIPOD+AIPrediction model reporting, including machine-learned models
IEC 62304Medical device software lifecycle processes
ISO 14971Risk management, where the technology is a device
EU MDR 2017/745Where software or a technology meets the device definition
STARD 2015Where the technology performs a diagnostic function
CONSORT-AI and SPIRIT-AITrials of artificial intelligence interventions
IEEE and discipline standardsFor the engineering journals and conferences you publish in
ISO 9001:2015The quality system the process itself runs under

Use of AI Tools

AI tools support search and formatting, not scientific writing

This policy applies to every service and every industry, regardless of deadline.

Our AI policy

Used forLiterature search expansion, de-duplication, reference formatting and consistency checks
Not used forDrafting argument, interpreting results, or generating text a reader will take as yours
DisclosedWhere a tool touched a deliverable, the handover says which tool and for what
Your dataNever used to train a model, and never sent to a service that would

How it works

A five-step process, starting with a free scoping read

We review your material before providing a quote.

One

Scoping read

A free review within two business days covering what the work needs, who would lead it and the cost.

Two

Named team

We tell you who is assigned and their relevant experience before work starts.

Three

Outline signed off

You approve each section, its content and its sources before drafting begins.

Four

Draft and review

Independent review, quality control and reference verification, each signed off separately.

Five

Handover

The deliverable with version-controlled working material, revised within the agreed scope.

Throughout

One named lead

One person leads the full project, keeping documents consistent.

Project Inputs

Send your existing material and we will identify any gaps

The scoping read includes a review of the material you provide.

You send

The source

Your existing material, templates and deadline.

We send back

A written view

A summary of available material, gaps and the condition of existing documents.

Then

A scope and a figure

Quoted per project, with the named team and the timeline, before you commit.

Our Experts

Our project team

Projects are assigned by subject and industry. Writers hold a master's degree or doctorate in life sciences, medicine, pharmacy or a relevant discipline, and have at least five years of experience in the field. Writers keep up to date with the guidance that governs their work.

Specialists for engineering and technology projects

Subject matter expertsAssigned based on your field
Information specialistsLiterature searches documented so they can be repeated
StatisticiansStudy design, analysis and reviewer-ready outputs
Sector specialistsFamiliar with the regulations that apply to this industry
Independent reviewersA second qualified reviewer who did not write the draft
Quality controlReference verification and consistency across a document set

Sample work

Example deliverables

Shared with client permission and redacted where requested.

Benefits

Benefits for engineering and technology clients

Practical benefits of working with Pubrica.

What you get

Traceable claimsEvery claim mapped to the evidence that supports it
Written for the reviewerWritten for the clinician, reviewer or assessor who approves the work
Engineering and clinical expertiseProjects spanning engineering and medicine are assigned a specialist from each
Unlimited revisions within the agreed scopeWithin the agreed scope, without a per-round charge
Code delivered with analysisSo validation results can be reproduced
You are the authorNamed throughout; we do not offer ghost authorship

Packages

Quoted per project, not per page.

Documents of the same length can need very different amounts of work, so we price each project on its scope. The free scoping read gives you a figure you can budget for.

First

Scoping read

Free, two business days. A written assessment of what the work needs.

Then

A written scope

Deliverables, standards, named team and timeline, agreed before work starts.

Quoted

Per project

One figure for the agreed scope, with revisions included rather than billed per round.

Quality Assurance

Revisions within the agreed scope

If the deliverable does not meet the scope you approved, we rework it at no extra charge and repeat the independent review.

What is covered

Unlimited revisionsWithin the scope agreed, with no per-round charge
Independent re-reviewA second qualified reviewer, not the original author, checks the rework
Correct guidance editionIf the wrong guidance edition was applied, we correct it
Clear scopingIf the original scope was wrong, we tell you rather than billing a change request

FAQs

Common questions from engineering and technology clients

Reports are often written for readers who already accept the approach. External reviewers need the test conditions, the comparator, the failure cases and performance on data the model has not seen. Reports that leave these out are more likely to be questioned.

If it makes a clinical claim, yes. TRIPOD+AI applies to prediction models, and CONSORT-AI or SPIRIT-AI apply if the algorithm is tested in a trial. Writing to these standards from the start is easier than revising a report later.

Broadly, when its intended purpose is medical. The answer depends on your specific product. The scoping read gives our view and notes where the boundary is unclear. More detail is on the medical devices page.

Yes. Our panel covers engineering and computer science as academic disciplines, and projects are assigned by subject.

We write the technical description, working alongside your attorney. We do not draft claims or advise on patentability, and your attorney manages the filing.

We do not build or validate your system, certify conformity to any standard or give legal advice. We write the documentation and papers. The engineering work and final sign-off remain with you.

Related Services

Related industries and services

Projects that span more than one sector can draw on specialists from each.

Other industries and subject areas

All industriesOverview of the twelve industries we support
Biologics and biosimilarsDocumentation for biologic and biosimilar programmes
GenericsDocumentation for generic and abridged applications
Medical devicesTechnical file and clinical evaluation documentation
Subject areasSupport organised by academic discipline
Therapy areasSupport organised by therapy area

Discuss your engineering or health technology project requirements

Send us your project details and deadline. Within two business days, at no cost, we provide a written scoping read covering what the work needs and who would lead it.

Get a free quote

Regulations

Check your project against this rule

  1. 1Your work
  2. 2Your details
  3. 3Send
What do you need?

Material you send is held under signed confidentiality, with access limited to the assigned team and encrypted transfer. It is not used to train anything and is not passed to third-party tools. Ask for the agreement before you send anything you would rather cover first.