Contract Manufacturing & Design

Contract Design and Prototype Services Brochure

Device Capabilities

We are capable of working to your specific designs and requirements. Whether you have engineering drawings or simply a good idea, we can design and develop your device. Brivant’s device capabilities include soldering of similar or dissimilar metals, UV, solvent and epoxy bonding. We also bond polymers, metals and glass fibre.

We also conduct validated tests for the characterization of devices

Product Validation

Our series of validated test methods will ensure that your device meets all safety and regulatory requirements and of course the device performs as you envisaged. Our dedicated team of R&D, manufacturing and validation engineers can modify or develop test methods to validate your device for particular properties or indications for use. External testing includes Biocompatibility, Transportation and Accelerated Aging, Animal Studies and Sterilization validation. If your device does not fit within already validated Brivant bookends we can develop new test methods to ensure conformance

Device Manufacture

Our engineers have years of experience with large multinationals to start ups. We ensure the transfer of a project from R&D into production is smooth and uninterrupted. This allows our customers to follow timelines and meet launch requirements.

Our custom built ISO Class 8 Controlled Environment is a purpose built manufacturing environment. Our highly trained operators and state of the art equipment allows us to meet your time demands and of course the high quality of service synonymous with Brivant

 

 

Regulatory

We have regulatory approvals under ISO 13485 (2003), CE – MDD & AIMDD and FDA / 510(k).

We are involved from design through validation and can deliver sterile, customer labeled product ready for clinical use.

Below are our CE Certificates. The EC Design Examination certificate and the Quality Approval certificate.

 

© Brivant Medical Engineering 2009

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