Contract Medical Injection Moulding

Tool and Gauge delivers unparalleled quality and innovation in medical component manufacturing. Partner with us for precision and reliability.

Tool & Gauge provides injection moulding contract manufacturing for MedTech and industrial manufacturers from our ISO 13485 certified facility in Tubbercurry, Co. Sligo, Ireland. Established in 1956, we build the mould, validate the process and mould your parts, with cleanroom moulding and assembly on the same site.

One partner from tooling to finished components means fewer handovers, faster changes and one quality system covering the whole job, for customers in Ireland, the UK, Europe, the US and further afield.

Our Commitment to Excellence

At Tool and Gauge, we are committed to investing in the cutting-edge technology and resources necessary to deliver medical components of the highest quality. Our unwavering dedication ensures that our products meet the stringent demands of the medical device industry.

Injection moulding machines in the cleanroom

Unmatched Quality
Investing in the best technology

Resource Allocation
Dedicated to superior component production.

Industry Leadership
Setting new standards in medical manufacturing.

Leveraging Our Expertise

Our customers in the medical device industry benefit immensely from our extensive experience and specialized expertise. We foster a collaborative environment, working closely with clients at every stage of the process, from initial concept to final production.

Collaborative Approach
We partner with you from design to delivery, ensuring seamless integration of our expertise into your project.

Experience Matters
Benefit from our deep understanding of medical device requirements and industry best practices.

Core Services in Medical Device Manufacturing

Our suitability as manufacturing specialists in the medical device industry is highlighted by the comprehensive range of core services we offer. Each service is tailored to meet the unique and critical demands of this sector.

Cleanroom Manufacturing

Ensuring clean production environments.

Validation

Rigorous testing for peak performance.

Contract Manufacturing

Producing high-quality precision parts.

Assembly

On-site assembly in controlled environments

Tool & Gauge engineer reviewing mould design with production team

State-of-the-Art Cleanroom Manufacturing

We have integrated and dedicated a 150m² purpose-built Class 8 Cleanroom. This facility is designed to meet the strictest standards for environmental control, ensuring the purity and safety of every component produced.

This advanced cleanroom is a testament to our commitment to providing a controlled environment essential for the production of sensitive medical devices.

Precision Contract Manufacturing

Tool and Gauge specializes in contract manufacturing of high-quality precision parts and critical components. These components are integral to a wide range of medical devices and apparatus, from diagnostic equipment to surgical tools.

Our advanced manufacturing capabilities ensure tight tolerances and consistent quality, making us a trusted partner for complex medical device projects.

Common Questions About Contract Medical Moulding

What MedTech buyers usually ask before moving a part into production with us.

What Is Contract Medical Injection Moulding?

It is the manufacture of plastic components for medical device companies under a medical quality system. We mould to your design in our ISO 13485 certified facility.

Which MedTech Areas Do You Mould For?

Our contract moulding covers components for vascular intervention, endovascular, structural heart, electrophysiology, drug delivery, surgical, endoscopic, and respiratory and nebuliser devices.

Do You Have a Cleanroom?

Yes. We have a dedicated 150 m² ISO Class 8 cleanroom for moulding and assembly of sensitive medical components.

Are You ISO 13485 Certified?

Yes. Our component manufacturing division is certified to ISO 13485:2016 and ISO 9001:2015.

What Materials and Machines Do You Use?

We mould medical-grade thermoplastics, silicone and engineering polymers on vertical and horizontal machines from 35 to 1,000 tonnes, for pilot builds through to high-volume production.

Can You Build the Mould and Mould the Parts?

Yes. Mould design, toolmaking, validation and production moulding are all done in-house, so one partner looks after your project from tooling to finished parts.

Do You Offer Assembly?

Yes. We carry out on-site assembly in controlled environments, so moulded components can leave as finished sub-assemblies.

Do You Supply International Customers?

Yes. Our contract moulding service is set up for international MedTech customers in the UK, mainland Europe, the US and further afield, with tooling, moulding, validation and assembly under one quality system in Tubbercurry.

Have a medical component to move into production?

Talk to our moulding team
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