Our extensive experience and advanced state-of-the-art facility provides a reliable high quality level of service demanded by the medical and healthcare sectors.
Medical
Specialists In Medical Device Manufacturing
Boddingtons specialises in the development and manufacture of mould tools, plastic injection moulded components and the assembly of complex devices for the pharmaceutical, drug delivery, medical, and healthcare industries. Our engineering expertise, which has been developed over forty five years serving these markets and by using the latest technology, ensures that consistent and superior quality can be found in all that we produce.
Medical & Technical Injection Moulding Specialists
Cleanrooms
Manufacturing & Assembly Cells within an ISO Class 7 Environment
Design to Industrialisation
From concept to Multi-Cavitation tooling with automated Assembly
Precision Tooling
Specialists in Design for Manufacture and Tooling Design and Build
Assembly & Services
Full product build Including testing, packaging and Sterilisation
Quality Assurance
ISO 13485, ISO 9001 and an FDA Registered Site
Seamless validation process
Fully documented APQP / IQ/OQ/PQ processes to support customer requirements
Cleanrooms providing controlled environments
Our state of the art facility proudly provides the space for our ISO Class 7 Cleanroom Environments. We strictly continually monitor Bio-burden levels to maintain our facilities to remove the risk to customers products and ultimately the patient in the field.
Design to Industrialisation
Boddingtons provides development & manufacturing services from product concept, through prototyping, mould making, validation and into high volume production.
Dedicated project teams ensure contribution from all areas of expertise throughout each stage of product development, ensuring smooth transition from design to industrialisation.
Precision Tooling In-House Reduces Lead Times
Precision toolmaking is crucial to the efficient manufacturing as it drastically reduces lead times allowing our customers to respond to quickly market demands.
In-house project team support the design and manufacture of injection mould tools to ensure that every detail of the component design is precisely reproduced whilst incorporating the specific needs of the selected polymer. Each tool is run through a trusted site acceptance test (SAT) and Factory Acceptance test (FAT) before entering into validation and production processes Learn More
Product Assembly & Services
Our plastic injection moulding facilities are complemented by Assembly rooms providing automated and manual completion of products within ISO Class 7 or White Room (Clean) environments.
Additional services include printing, Ultra Sonic Welding, Heat Staking, Packaging development including Sterilisation Management.
Quality Assurance
Our Quality Management systems accredited to ISO 13485:2016 supports everything we do for our customers. Boddingtons also manages Regulatory Affairs for customer products either by supporting customer queries or handling the full technical file including registrations such as CE or FDA, 510k.
Rigorous & seamless validation process
Boddingtons is committed to meeting customer specifications in relation to design, manufacture and qualification requirements of all processes, facilities and equipment. Design, installation, operational and performance qualification ensure complete and seamless validation.
Controlled environments providing compliant solutions for the meticulous demands of the medical sector.
Fully certified ISO Class 7 Cleanroom environments including flexible mobile systems.
Advantages of Injection Moulding with Boddingtons
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Unrivalled Experience
Plastic processing in all varieties of polymers used in the production of medical devices including assembly
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Precision Injection Moulding
Plastic injection moulding of precision components is our core business
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Class 7 Cleanrooms, Whiteroom Manufacture
Including customer specific manufacturing cells
Working under the Quality System ISO13485 we can provide:
- A regulatory controlled environment
- An appropriate validation process
- Support and advice on achieving regulatory compliance
- Technical files
- Process and support for CE marking and FDA approvals
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Assembly & Services
Automated & hand assembly and value added operations
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Bespoke Manufacturing Cells
Customer specific medical device manufacturing cells
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Clinical Trial Builds
We provide bespoke solutions through clinical trial build processes
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Validation & Qualification
Full validation of mould tools, processes and equipment
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ISO 13485:2016
Quality Assurance, Control and management systems
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Regulatory affairs management
Technical File Generation, Ongoing Maintenance, Registration for CE/FDA/UKCA
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Endoscopy Devices and Accessories
Class 2 Medical Devices to Disinfectant Control Management
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Diagnostic Devices
Equipment, Housings, Pump Controls and Consumables
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Pharmaceutical Filters and Disposable Devices
Vaccine generation, protein filtration, Valve Systems
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Single Use Devices
High Precision Moulding with Assembly of Advanced Engineering Plastics
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Testing Equipment and Receptacles
High and Low Volume Manufacture testing and assembly