Quality is our key focus and is underpinned by a culture of continuous improvement. Our goal is to minimise your risk and achieve outstanding consistency in product manufacture. Our quality control systems and proactive regulatory support encompass both ISO9001 and ISO13485.
Quality
Regulatory Management
The regulations surrounding medical device manufacture and supply can be a minefield. We have our own Regulatory Manngement to enable Boddingtons to provide support and ownership of every detail from building technical files, registration with appropriate regulatory bodies, to supporting the program with ongoing product surveillance.
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.
Measurement Systems
Vision Measuring Systems
High Speed CNC driven measuring machine offering time saving on metrology
Computer Measuring Systems
More conventional machines offering large machine bed for a variety of parts
Optical Vision Systems
Visual inspection made easy with optical visual checking for those finer details
Gauges
In process checks in cycle at the machine taking subjectivity from any operator
Test Equipment
Pressure decay, vacuum, tensile or torsion testing available in house
Callipers
Speedy measurements for peace of mind maintaining product within specification
Validation
Understanding the requirements for approval is critical from the outset. Boddingtons approach is well documented and offers flexibility to meet the customer needs. From Machine, Mould tool, process, Product including transit validation, Boddingtons support is invaluable.
Capability
Maintaining product specification throughout the process is critical. Using statistical data, taking strategic samples and mapping these through our validation software, we are able to document and offer peace of mind throughout the manufacture process that we can meet and maintain the high demands of the customer.
Auditing
High standards do not come from just the great team at Boddingtons. We maintain our robust processes and procedures and challenge every part of our business at every level. Our continuous improvement journey is a road to the being the ultimate support partner.
Advantages of Injection Moulding with Boddingtons
-
Material Processing
From polypropylene, polycarbonates to high glass content nylons including PEEK
-
Fully Flexible Production Press
From 50 ton to 850 Ton presses including Tie-barless machines
-
Shop Floor Data Collection
Using the latest software technologies, linked to every machine, Boddingtons is able to monitor machine utilisation and efficiency to maintain