Diagnostics advisory and solutions
Helping the diagnostics sector grow, comply and perform.
POCTIFY is a UK advisory firm for in vitro diagnostics and laboratory medicine. We help manufacturers and distributors reach new markets, help laboratories and testing services meet the standards, and build the digital tools that keep governance part of daily work.
- NHS DSPT: Standards Met
- Cyber Essentials certified
- ICO registered
- ISO 15189:2022 aligned
Partners
Who we are
One partner across strategy, regulation, quality and technology
Diagnostics is a regulated, technical and fast moving market. Getting a product to the people who need it, or running a laboratory to the standard patients deserve, takes more than one kind of expertise.
Our advisors bring laboratory, industry and digital experience to the same table. We work with manufacturers, distributors, laboratories and healthcare providers in the UK and internationally, and we stay until the work is in place.
What we do
Our services
Five areas of work. Take one, or combine them into a single programme with one team accountable for the result.
Advisory and strategy
Independent advice for diagnostics businesses, laboratories and healthcare providers: where to invest, what to fix first and how to get there.
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Market access
We help manufacturers and distributors enter new markets and grow in them, from entry strategy and partner representation to building a distribution network.
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Regulatory and quality governance
Readiness for ISO 15189:2022 and regulatory pathways, independent audit and the documented systems assessors and buyers expect to see.
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Digital solutions
Governance software and digital quality systems that join up devices, results and records, so the evidence exists as the work is done.
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Laboratory transformation
Planning and implementation for new and changing services: device selection, workflows, training and go live, delivered alongside your team.
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Not sure where to start?
Tell us what you are trying to achieve. We will tell you honestly what is worth doing, in what order, and what it should cost.
Talk to our teamMarket access
For manufacturers and distributors entering new markets
A good product still needs the right route to market. We help you choose where to go, who to work with and how to win the confidence of laboratory and clinical buyers.
- Market entry strategyMarket assessment, positioning and a realistic launch plan.
- Partner representationA credible local presence with buyers, networks and decision makers.
- Distribution networksFinding, assessing and supporting the right distribution partners.
- Regulatory pathway supportClarity on registration and evidence requirements before you commit.
Solutions
IT and governance solutions for laboratories and testing services
We design and build software that makes quality and governance part of the daily routine, not a scramble before an assessment.
- Governance softwareCompetency, non conformances, corrective actions, audits and management review.
- Digital quality systemsControlled documents and records that map to ISO 15189:2022.
- Joined up dataDevices, results and records brought together in one place.
- Oversight and reportingDashboards across sites, devices and teams for the people accountable.
Sectors
Who we work with
IVD manufacturers
Market entry, positioning and the evidence buyers ask for.
Distributors and importers
New product lines, new territories and stronger partner support.
Hospital and private laboratories
Accreditation readiness, transformation and digital governance.
Point of care and community testing
Services outside the laboratory, run to a laboratory standard.
Clinics, pharmacies and healthcare groups
Setting up testing services that are safe and defensible.
Health technology companies
Supplier readiness and routes into diagnostics services.
How we work
A clear engagement model
Every engagement follows the same four stages, whether it is a two week review or a year long programme.
- 01
Understand
A scoping conversation and a review of where you are today, your goals and your constraints.
- 02
Plan
A written proposal with priorities, deliverables, timeline and a fixed fee wherever the scope allows.
- 03
Deliver
Our team works alongside yours, with regular reporting and one accountable lead.
- 04
Sustain
Handover, training and ongoing support, so the results last after we step back.
Why POCTIFY
Independent, standards led and practical
We are independent of analyser makers, so our advice follows the evidence. We name the standards we work to, and we write in plain language that busy teams can act on.
- Laboratory, industry and digital experience in one team.
- Standards named. ISO 15189:2022, MHRA guidance and CLSI protocols, cited by clause.
- Governed like a supplier should be. NHS Data Security and Protection Toolkit standards met, Cyber Essentials certified, ICO registered.
- Built for public and private buyers. NHS purchase orders accepted and published policies.
- UK based, working internationally. Registered in England and Wales and based in London.
Insights
Our latest thinking
Connected is not governed: what data integrity really asks of a POCT service
Linking point-of-care devices to the record removes transcription error. It does not prove who ran the test, whether they were competent, or whether the controls were accepted. That evidence is still the service's job.
Quality scienceHow good is good enough? Setting and verifying analytical performance for POCT
Before a point-of-care device goes live, someone has to decide how much bias and imprecision this clinical use can tolerate, and then prove the device meets it on site. Most services skip the first step.
GovernanceOne patient, five numbers: identity and record matching when POCT leaves the hospital
A correct result attached to the wrong person, or to nobody, is a patient-safety failure. Outside the hospital the identifiers multiply, and the controls that hold them together thin out.
FAQ
Questions people ask
What does POCTIFY do?
POCTIFY is a UK advisory and solutions firm for the in vitro diagnostics and laboratory sector. It provides advisory and strategy, market access for manufacturers and distributors, regulatory and quality governance support, laboratory transformation and implementation, and digital governance solutions.
How does POCTIFY help diagnostics manufacturers and distributors?
Through market access work: market entry strategy, partner representation, building and supporting distribution networks, and regulatory pathway support, so a product reaches the laboratories and services that need it.
What digital solutions does POCTIFY provide?
POCTIFY builds governance software and digital quality systems for laboratories and testing services: competency, quality records, non conformances and corrective actions, audits, and dashboards across sites. It is workflow and record keeping software and does not interpret clinical results.
Who does POCTIFY work with?
IVD manufacturers, distributors and importers, hospital and private laboratories, point of care and community testing services, clinics, pharmacies and healthcare groups, and health technology companies, in the UK and internationally.
Is POCTIFY an NHS-ready supplier?
POCTIFY LTD has met the NHS Data Security and Protection Toolkit standards (version 9), holds Cyber Essentials certification, is registered with the ICO, and accepts NHS purchase orders with 30 day terms. The company is registered in England and Wales and based in London.
How does an engagement start?
With a short scoping call. We then send a written proposal with priorities, deliverables, timeline and fee. Book a call or email info@poctify.com.
Talk to our team
Tell us where you want to grow or what you need to fix. We will come back with a clear, written proposal.