ISO 13485 accredited manufacturing

Managing in-house and outsourced tooling, setup, batch and ongoing production.

Background

Lucid Group is BSI accredited to manufacture 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 out-sourced production, test, assembly and stock management compliant audited compliant to ISO 13485.

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

The products and prototypes that Lucid’s team makes 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

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.