Medical device manufacturing sits between two disciplines that rarely share a language. On one side is a quality system built around ISO 13485 and risk management. On the other is a physical facility: cleanrooms, utilities, automated assembly, sterilisation. The regulator will hold you to both, and the facility is usually the harder one to change once it is built.

Projex Solutions provides multi-disciplinary engineering design, validation support and EPCM project delivery to medical technology manufacturers across the UK. We design the facility around the quality requirement rather than expecting the quality system to compensate for the building.

The pressures our medical technology clients are managing

A regulatory framework in transition. The Medical Devices Regulations 2002 remain the operative pre-market law in the UK. The Medical Devices (Post-market Surveillance Requirements) (Amendment) Regulations 2024 came into force on 16 June 2025, strengthening surveillance, reporting and field safety corrective action duties. A new UK pre-market statutory instrument is planned, and a consultation on indefinite recognition of CE-marked devices in Great Britain closed in April 2026.

Because that position is genuinely live, we would confirm the current recognition dates with you at the point of engagement rather than design a capacity plan around a date that has since moved.

Capacity decisions with a deadline attached. Where CE recognition end dates apply, they create a hard planning horizon for manufacturers considering reshoring, expansion or a second production line. Facility projects of that scale need eighteen months to two years of lead time, which makes the decision point earlier than most boards expect.

Cleanroom performance as evidence. Design to BS EN ISO 14644-4:2022, with classification and monitoring to Parts 1 and 2, is what turns a controlled environment from an intention into a demonstrable control.

Sterilisation brings process safety into scope. Ethylene oxide handling carries DSEAR duties, hazardous area classification and potentially environmental permitting obligations that device manufacturers rarely hold in-house.

Validation. IQ, OQ and PQ across automated assembly, sterilisation and packaging lines, with traceability into the ISO 13485 quality system.

Where we add value

Cleanroom design, build management and qualification. Design to BS EN ISO 14644-4:2022, covering airflow strategy, pressure regime, material and personnel flow, and the classification and monitoring approach that will be tested at audit.

Utilities design. HVAC, compressed air, process gases, purified water and vacuum, designed with sampling points and qualification in mind.

Process validation support. IQ, OQ and PQ protocol development and execution for production, sterilisation and packaging equipment.

DSEAR and hazardous area classification where ethylene oxide, solvents or flammable adhesives are handled, with CompEx-certified engineers.

Capacity expansion and reshoring projects. Feasibility and FEED work that establishes what a second line or a new facility actually costs and how long it takes, before the commitment is made.

Automation and line integration. Machinery safety, PUWER compliance and the practical business of integrating automated assembly into an existing building.

3D laser scanning for accurate survey of existing production space ahead of layout change.

CDM 2015 duty holder support and EPCM delivery under ISO 9001:2015 certified project methodology.

Related sectors

Medical technology manufacturing shares a great deal of engineering ground with pharmaceutical facility work, particularly around cleanrooms, clean utilities and qualification.

When clients typically call us

  • A cleanroom needs designing, extending or requalifying
  • Capacity has to increase ahead of a regulatory transition deadline
  • A notified body or MHRA audit has raised findings against facility, utilities or environmental control
  • Sterilisation plant brings DSEAR and permitting duties the business does not currently cover
  • An automated line is being introduced into a building that was not designed for it
  • Production is being reshored and the facility case needs building from first principles

Why medical technology manufacturers work with Projex

We work across regulated manufacturing rather than in a single vertical, and that turns out to be an advantage here. The cleanroom and clean utility disciplines that medical device manufacturing depends on are the same ones we apply on pharmaceutical facilities, and the process safety competence we bring from chemical work is exactly what is missing when ethylene oxide sterilisation enters the picture.

Our teams work from Brighouse in West Yorkshire and the Wilton Centre in Redcar. We are certified to ISO 9001:2015, SafeContractor approved, and hold a Bronze EcoVadis sustainability rating.

Frequently asked questions

Do you design cleanrooms?
Yes, to BS EN ISO 14644-4:2022, including classification strategy, pressure cascade, and the material and personnel flows that determine whether the classification holds in practice.

Can you support validation?
Yes. We develop and execute IQ, OQ and PQ protocols for production, sterilisation and packaging equipment, documented for traceability into an ISO 13485 quality system.

We use ethylene oxide sterilisation. Is that in scope for you?
Yes, and it is an area where we would expect to add most value. EO handling brings DSEAR duties, hazardous area classification and potential permitting obligations that most device manufacturers do not resource internally.

How early should we start a capacity project?
Earlier than most people assume. A new line or facility typically needs eighteen months to two years from concept to qualified production, so a regulatory deadline two years out is a decision point now.

Talk to us about your facility. Request a call