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BioFlex Engineering

Production tooling for medical manufacturing.

Jigs, fixtures, workbenches, and process tooling, designed for cleanroom and ISO-controlled environments.

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Equipment around the device

Ireland is one of the world's leading medical device hubs, home to nine of the top ten global medtech companies and over 300 manufacturers. BioFlex provides the mechanical engineering support that keeps production lines running: jigs, fixtures, ergonomic workbenches, and process tooling designed for cleanroom and ISO-controlled environments. We focus on the equipment around the device: the tooling that holds it during assembly, the workstation it is built on, and the production aids that keep the line moving.

We do not design medical devices themselves. Our focus is on the equipment and fixtures that surround the device: the tooling that holds it during assembly, the workstation it is built on, the rack it is transported on, and the production support equipment that keeps the line running.

Services

Assembly jigs and fixtures
Manual, semi-automated, and fully automated.
Test and inspection fixtures
For in-process and end-of-line verification.
Ergonomic ESD-safe workbenches
Designed for cleanroom integration.
NPI and R&D phase concept tooling
Rapid iteration, weeks not quarters.
Process design and line flow
Fixture-to-fixture sequencing, ergonomic layout.
Fume extraction (LEV)
For soldering, bonding, and adhesive operations.
Cleanroom-compatible storage
Shelving, racking, kanban systems.
Reverse engineering of legacy fixtures
Modernisation and like-for-like replacement.

Compliance & standards

BioFlex designs to cleanroom constraints: ISO Class 7 and 8 compatible materials, ESD-safe surfaces, low-particulate finishes, and cleanability for CIP and manual cleaning. We work to your QMS and documentation standards and provide full material traceability.

Why choose us

Direct experience inside major Irish medtech manufacturers
We understand your environment and constraints.
Fast iteration
Working concept fixture delivered in weeks, not quarters.
Cost-effective alternative
To large consultancies for jig and fixture work.
Familiar with cleanroom integration
Lean line layout, and ergonomic standards.

Recent medical engineering projects.

A selection of fixture, tooling, and mold projects delivered for medical and pharmaceutical manufacturers.

Assembly fixture

Fig. 01

Two-cavity assembly fixture with locator pins for medical device component positioning

Two-cavity component fixture

A precision dual-cavity assembly fixture designed for repeatable positioning of small medical components during manual assembly operations. Integrated locator pins ensure consistent orientation and reduce operator variability. Machined from aluminium with hard-anodised finish for cleanroom compatibility.

2-cavity · Aluminium · ESD-safe · ISO Class 7 compatible

Thermoform mold

Fig. 02

Eight-cavity thermoform mold tool with formed PETG packaging trays for medical applications

8-cavity medical tray mold

Custom thermoform mold tool designed for the high-volume production of medical-grade PETG packaging trays. The 8-cavity layout maximises throughput per cycle while maintaining tight dimensional tolerances required for sterile packaging applications. Designed with optimised drainage geometry and uniform wall thickness for consistent forming quality.

8 cavities · PETG compatible · EU 10/2011 · Drainable geometry

Reverse engineering

Fig. 03

Stainless steel filling funnel, redesigned and manufactured to replace failed plastic version

Stainless steel filling funnel

Originally manufactured in plastic, the existing filling funnel suffered from low mechanical strength and repeated failure under operational stress. BioFlex redesigned and manufactured the component in stainless steel, improving durability, hygiene compliance, and resistance to wear. The redesigned funnel maintains the original geometry while delivering significantly extended service life.

Stainless steel · Reverse engineered · Hygienic finish · Extended service life

Got a jig, fixture, or tooling challenge?

Send us your problem. We'll come back with a scoping outline within 5 business days.

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