ConsultingDesignSimulationAutomationInspectionValidationAI & SoftwareValuation

Engineering, validation and intelligence for high-performance industries.

OneFit Projects is a multidisciplinary engineering house serving 24 industry verticals through 20 integrated capabilities. From feasibility and design to machines, inspection, qualification, AI and asset valuation, one accountable team owns the outcome.

Quality & regulatory

Compliance by design

ISO, ASME, PED, FDA, GAMP 5 and IEC frameworks engineered in from day one, not audited in at the end.

ISOASMEPEDFDAGAMP 5IEC
26 standards and codes we design to View standards
200+
Projects delivered
50+
Clients & consultants
20
Industry verticals
10+
Years of engineering
ISO 9001ISO 13485ISO 14971IEC 6060121 CFR 820 / QMSRGAMP 521 CFR Part 11ASME BPVC VIIIASME B31.3PED 2014/68/EUAPI 650 / 620AWS D1.1ISO 12100IEC 62061 / ISO 13849IEC 61508 / 61511ISO 10218AS9100IATF 16949ISO 26262ISO 55000ISO 50001ISO 9712 / ASNT SNT-TC-1AIEC 62443ISO/IEC 42001ISO 17025IVS / RICS Red Book ISO 9001ISO 13485ISO 14971IEC 6060121 CFR 820 / QMSRGAMP 521 CFR Part 11ASME BPVC VIIIASME B31.3PED 2014/68/EUAPI 650 / 620AWS D1.1ISO 12100IEC 62061 / ISO 13849IEC 61508 / 61511ISO 10218AS9100IATF 16949ISO 26262ISO 55000ISO 50001ISO 9712 / ASNT SNT-TC-1AIEC 62443ISO/IEC 42001ISO 17025IVS / RICS Red Book

What we do

Five practice groups. One engineering bench.

Most engineering vendors do one thing. Industrial problems rarely respect those boundaries. Our advisory, engineering, quality, digital and operations teams work as one, so design decisions, control constraints, compliance evidence and data plans get made together.

Industries

24 industry verticals, from regulated to heavy

Medical devices to mining, pharmaceuticals to power. Codes and regulators change between sectors; our standard of evidence does not.

Medical DevicesDesign, validate and manufacture devices that regulators trust and clinicians rely on. PharmaceuticalGMP facilities, equipment and systems qualified for global regulatory inspection. Biotech & Life SciencesLab to commercial scale, engineered for biological processes. Aerospace & DefencePrecision engineering, analysis and qualification for flight and mission-critical systems. Automotive & EVProduction lines, test systems and analytics for the electrified vehicle era. Oil & GasIntegrity, inspection and engineering for upstream, midstream and downstream assets. Power & EnergyEngineering for thermal, hydro, nuclear-adjacent and grid infrastructure. Renewables & StorageSolar, wind, hydrogen and storage engineered for bankable performance. Chemicals & ProcessProcess, mechanical and safety engineering for plants that run hot, high and hazardous. Food & BeverageHygienic design, automation and traceability for safe, efficient food production. Water & WastewaterTreatment, pumping and control systems engineered for uptime and compliance. Infrastructure & ConstructionStructural, mechanical and inspection engineering for the built industrial environment. Mining & Heavy EquipmentHeavy-duty engineering for equipment that works in the harshest environments. Steel & MetalsProcess, equipment and digital engineering for metal producers and processors. Electronics & SemiconductorCleanroom facilities, precision automation and thermal engineering for electronics. Packaging & FMCGHigh-speed lines, changeover flexibility and zero-defect quality. Rail & TransportationRolling stock, infrastructure and depot engineering for safe, reliable transport. Marine & OffshoreStructures, systems and inspection for vessels, ports and offshore assets. Data CentresCooling, power and monitoring engineering for facilities that cannot go down. TextilesMachinery, automation and sustainability for a modernising textile industry. Agriculture & AgritechMachinery, automation and data for productive, sustainable agriculture. Logistics & WarehousingAutomated storage, handling and data systems for high-velocity supply chains. Consumer ProductsDesign, engineering and manufacturing support for products people use every day. Education & ResearchLaboratories, research equipment and industry-grade training for the next generation of engineers.

Why industrial leaders choose OneFit Projects

Built to be the engineering partner you call first

Global OEMs, plant owners, EPC contractors, investors and institutions work with us because we combine the depth of a specialist with the breadth of a full-service house, and because we put our name on evidence, not opinions.

One accountable team

Mechanical, controls, software, AI, quality and valuation engineers on the same bench. No handoffs between vendors, no gaps.

Audit-ready evidence

Calculations, protocols, inspection records and reports written for regulators, notified bodies, lenders and insurers.

Regulated-industry discipline

Medical and pharmaceutical validation rigour applied wherever quality and safety are critical.

Measured outcomes

Cycle time, uptime, yield, energy, compliance findings. We agree the metrics up front and report against them.

How we deliver

Six stages from first conversation to lifetime support

Adapted to the size and complexity of your project. Never skipped.

01

Discover

Site walk-downs, stakeholder interviews and data review to fix the real problem, constraints and acceptance criteria before any design work begins.

02

Define

Requirement specifications, risk registers, budgets and schedules signed off with your team. Every downstream decision traces back to this baseline.

03

Design & simulate

Concept trade-offs, detailed engineering, FEA/CFD and digital models so decisions are made on evidence, not opinion.

04

Build & integrate

Fabrication management, machine build, controls, software and AI brought together as one system under one accountable team.

05

Validate & inspect

FAT/SAT, IQ/OQ/PQ, NDT, dimensional and functional inspection against the agreed criteria, with full traceable documentation.

06

Operate & improve

Handover, training, condition monitoring and continuous improvement programmes that keep assets performing for their whole life.

Standards & compliance

Codes, standards and regulations we engineer to

A selection of the frameworks our teams design, validate, inspect and document against. Compliance is designed in, not audited in.

ISO 9001
Quality management systems
ISO 13485
Medical device quality management
ISO 14971
Medical device risk management
IEC 60601
Medical electrical equipment safety
21 CFR 820 / QMSR
US FDA quality system regulation
GAMP 5
Computerised system validation
21 CFR Part 11
Electronic records & signatures
ASME BPVC VIII
Pressure vessel design
ASME B31.3
Process piping
PED 2014/68/EU
European pressure equipment
API 650 / 620
Storage tank design
AWS D1.1
Structural welding
ISO 12100
Machinery safety & risk assessment
IEC 62061 / ISO 13849
Functional safety of machinery
IEC 61508 / 61511
Functional safety, process industry
ISO 10218
Industrial robot safety
AS9100
Aerospace quality management
IATF 16949
Automotive quality management
Full standards list

Trusted by

Clients and consultants who rely on us

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Our clients

About OneFit Projects

From mechanical design house to full-spectrum engineering partner

OneFit Projects began as a mechanical design, analysis and consultancy practice. As clients asked us to solve more of their problems, we added automation, special purpose machines, software, applied AI, validation, inspection and asset valuation. The principle never changed: the engineer who understands the physics should also understand the code, the regulation, the data and the commercial consequence.

For OEMs & manufacturers

Product development, machines, lines, automation, inspection and digital systems.

For plant owners

Integrity, reliability, validation, energy, modernisation and life extension.

For investors & lenders

Valuation, technical due diligence, lender's engineer and construction monitoring.

For institutions

Research partnerships, laboratories, training programmes and technology transfer.

Tell us about the problem you are trying to solve

Share scope, constraints and timeline. A senior engineer will respond with a practical path forward, whichever discipline it touches.