ISO 13485-Certified Moulding in the UK

40 of 446 verified UK manufacturers on cmgraph's Injection Moulding — UK lens hold ISO 13485 9% of the cohort.

The medical-device quality-management standard. For a moulder it signals audited device-grade process control; paired with a classified cleanroom it is the full medical-moulding stack.

Also known as medical device QMS or ISO 13485 certified moulding.

Ranked by verified factslens 0.3.6vocab 2026-07-28how this list is built →
#ManufacturerTownRegionVerified
1Advanced Plastics

Large-format injection moulding: 70 presses, high-volume automotive

HullYorkshire and the Humber33 facts
2Rutland Plastics

30 presses, assembly, contract machining, ISO 9001

RutlandEast Midlands30 facts
3ENL

Tech plastic injection molding & tooling; AS9100D, IATF 16949, 24/7.

PortsmouthSouth East29 facts
4Sovrin Plastics

ISO 13485, cleanroom, in-house tooling, high volume

SloughSouth East29 facts
5White Horse Plastics

Injection molding, ISO 13485, cleanroom, ultrasonic welding, overmolding, assembly

FaringdonSouth East29 facts
6A K Industries

A K Industries Limited is a UK-based contract manufacturer specializing in precision plastic injection moulding, offering a full spectrum of services from concept to production. Established in 1986, they differentiate themselves through advanced metrology, automation, and a Class 7 clean room, holding key accreditations including ISO 13485.

HerefordWest Midlands26 facts
7Andel Plastics

Injection molding, ISO 9001, cleanroom, pad print, ultrasonic weld, insert mold, prototypes.

BirminghamWest Midlands26 facts
8Gwalia Healthcare

ISO 13485 medical device containers; ISO 8 cleanroom IM

PontypriddWales24 facts
9Plastic Supplies Dudley

Plastic Supplies Dudley Limited is a UK-based, third-generation family-run plastic injection moulding specialist with over 50 years of experience and a 24/7 operating facility. They differentiate themselves through bespoke mould tool manufacture, rapid prototyping within 10 days, and ISO 9001:2015 and ISO 14001:2015 accreditations.

Brierley HillWest Midlands24 facts
10Data Plastics

Drug delivery components; ISO 13485 certified; high-volume production

OxfordSouth East23 facts
11Medical Moulded Products

Clean injection moulding, ISO 7, ISO 13485, ultrasonic welding, overmoulding

Burton-On-TrentWest Midlands21 facts
12Skar Precision Mouldings

Plastic injection moulders; ISO 13485, micro-moulding, DFM, assembly, 35 presses

IpswichEast of England21 facts
13Technimark

ISO 13485, Fanuc presses, DFM, prototypes, assembly, recycled content

Barnard CastleNorth East21 facts
14OGM (SW)

Plastic moulding: ISO 7 cleanroom, high volume, medical grade

KidlingtonSouth East20 facts
15OGM Moulding

OGM Medical is a UK-based contract manufacturer specializing in plastic injection moulding for the medical device industry, operating from two UK sites with 200 staff. Established in 1962 and accredited to ISO 13485, they offer comprehensive services from mould design to post-moulding assembly and validation.

OxfordSouth East20 facts
16Omega North East

Injection molding: design-build tooling, high-volume production & assembly.

GatesheadNorth East20 facts
17Proto Labs,

Digital rapid prototyping & on-demand production; AS9100, ISO 13485, ISO 9001

TelfordWest Midlands20 facts
18W.e.amies & Company

ISO 13485, Arburg, scientific moulding, bio-based materials

ChesterfieldEast Midlands20 facts
19Owen Greenings & Mumford

Plastic injection moulding — ISO 13485, ISO 7 cleanroom, in-house tooling

KidlingtonSouth East19 facts
20Prototype Projects

Prototyping & low-volume production; DFM, injection moulding, painting

HertfordshireEast of England18 facts
21Amies Innovation

ISO 13485, Arburg, twin-shot, overmolding, insert molding

ChesterfieldEast Midlands17 facts
22Moss Products Plastics

Custom plastic injection moulding — IML, thin-wall, cleanroom, Netstal

DunstableEast of England17 facts
23R.a.labone & CO

R.A. Labone & Co. Limited is a UK-based, privately-owned contract manufacturer offering end-to-end product realization services from concept to volume production, specializing in plastic injection moulding, insert moulding, and metal pressings. Established in 1963 and approved by various prime contractors, they provide a comprehensive, integrated approach to complex manufacturing needs.

IlkestonEast Midlands17 facts
24Alltrista Plastics

Injection moulding: ISO 13485, prototype tooling, closures

ChristchurchSouth West16 facts
25MI3

Medical device specialists — ISO 7 cleanroom, moulding, welding, assembly

Colwyn BayWales16 facts
26Hymid Multi-shot

Injection moulding: twin-shot, overmoulding, ISO 9001, Arburg.

TorquaySouth West15 facts
27Cybertools

Injection mould tool design & build; ISO 13485, high-volume parts

BuntingfordEast of England14 facts
28Proampac Lincoln

Food contact compliant; prototype capability.

LincolnEast Midlands14 facts
29Techniplas

Injection moulding; 1-600g parts; assembly; high/low volume; medical devices

HarlowEast of England14 facts
30Anderside Tools

Plastic injection moulding; 30-350t presses; medical specialist; ISO 13485

GlasgowScotland13 facts
31Glossbrook Engineering

Precision injection moulding (25-500T Krauss Maffei) — in-house tooling, medical, consumer, industrial.

BathgateScotland13 facts
32Rosti UK

Rosti UK Ltd. is a global contract manufacturer specializing in precision plastic injection moulding and end-to-end production solutions across thirteen international sites. Established in 1944, they offer extensive capabilities including In-Mould Decoration.

YorkYorkshire and the Humber13 facts
33The West

Miniature fluid control components; ISO 13485, high-volume injection moulding.

WaterloovilleSouth East13 facts
34Ennovi Advanced Mobility Solutions UK

Injection molding, mech assembly; high vol; IATF 16949, ISO 13485, 14001, 9001.

ArbroathScotland12 facts
35Splice Cast

High-volume injection moulding for packaging; ISO 13485 certified

ChorleyNorth West12 facts
36Invibio Device Component Manufacturing

INVIBIO DEVICE COMPONENT MANUFACTURING LIMITED is a UK-based contract manufacturer specializing in implant-grade PEEK and PAEK polymers for the medical device industry, utilizing Victrex's production capacity for global supply. Their strongest differentiator is their PEEK-OPTIMA™ polymers, with over 20 years of clinical history and zero material-related recalls across more than 15 million implanted devices.

Thornton CleveleysNorth West10 facts
37Malvern Medical Developments

Manufacturer: fabrication, finishing.

WorcestershireWest Midlands10 facts
38P3 Medical

P3 Medical Limited is a UK-based contract manufacturer with extensive experience in plastic and rubber extrusion, injection moulding, and precision packaging within clean room environments. With over 25 years of experience and ISO 13485:2016 certification, they offer a comprehensive "low mileage solution" for medical device development and supply.

South West9 facts
39Medasil Surgical

ISO 13485 medical device mfg; cleanroom class 8

LeedsYorkshire and the Humber6 facts
40Treasure Wright (U.K.)

Medical device injection moulding: ISO 13485, high/low volume.

LondonLondon6 facts

Related capabilities