Specialist assembly

Lucid Innovation ISO 13485 accredited manufacturing example

Background

Lucid Group is a British Standards Institution ISO 13845 accredited manufacturer of medical devices.  We provide integrated design, manufacturing, and regulatory support services for testing including:

  • Biological safety and compatibility.

  • Electrical safety and EMC.

  • Disinfection and sterility testing.

  • Accelerated aging and shelf-life.

  • Human factors engineering studies.

  • Clinical investigations.

Batch production capability for medical and non-medical devices includes:

  • Management of outsourced production, test, assembly, and stock management audited compliant to ISO 13485.

  • UKCA and CE product certification and maintenance and FDA clearance.

Lucid Innovation manufacturing example

 

The products and prototypes that Lucid’s team make and supply include:

  • Complex electro-mechanical medical devices with digital interoperability.

  • Mechanical medical device assemblies with complex regulatory compliance documentation.

  • Non-medical electro-mechanical products.

Facilities and Network

In-house facilities, skills, and experience include:

  • 3D print components, tooling, jigs and fixtures.

  • Vacuum casting.

  • Vacuum forming.

  • Film welding and sealing.

  • Laser cutting and engraving.

  • Light assembly areas.

  • Traditional workshop.

  • Controlled stockholding.

Internationally and in the UK we maintain relationships with reliable providers of production processes including:

  • Electronics PCB and harnesses.

  • Plastic and rubber mouldings.

  • Print and applied decoration.

  • Metal machining, mouldings, fabrication and finishing.

  • Sheet and film materials.

Tooling and setup

In-house at Lucid we manufacture 3D print, cast and fabricated tooling and jigs for all our in-house processes.

Our engineers have developed unique methods to manufacture specialist components and assemblies.

Testing and validation

In-house Lucid has many of the test tools required in IEC 60601 compliance.

Our team’s capabilities in electronic and mechanical design enable custom jig and fixture design for production verification.

Results

Lucid’s broad capabilities are a great fit for businesses that need reliable, accredited production support.

Previous
Previous

Traditional workshop

Next
Next

Film welding