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Prototype device manufacture and small volume productionomsbar 3 squares icon

We understand both the need for and the shortage of ISO13485 accredited facilities for the small manufacturer and the development entrepreneur.

So where do you get a small quantity of medical devices manufactured, packed, sterilised and validated?

Where do you find an ESD compliant electronics assembly facility?

A PCB assembly; part of a software controlled pneumatic assembly jig

Where do you find someone who will make a prototype device?

All within an ISO13485 accredited environment?

It is easy to find a clean room that will make you 100,000 devices (in Class 4, not so easy though!). Contract assemblers are happy to make 1,000 electronic assemblies per month for you.

But who wants to make 10 devices or even 1 device? Where can you discuss a prototype product and carry out some investigative and developmental work to fine tune your device?

A series of high density polyurethane castings  created for a medical device project .  This process provides low tooling costs and high quality components:  ideal for small production run devices.

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We were confronted with these problems ourselves and set up this facility accordingly – you can now enjoy the benefits of a small-scale manufacturing and developmental facility without the overheads and lead times associated with a large manufacturing facility.

We understand ISO13485 and the constraints that material sourcing, inspection, testing supplier approval, process validation etc impose on prototypes – let us assist you in making the transition from an idea to small-scale manufacturing as quickly and cost-effectively as possible.

We also have extensive experience of scaling up production afterwards too and you can be sure that our ISO13485 accreditation will provide the right regulatory structure for CE marking these devices.

Part of a software controlled pneumatic  assembly jig used in clean room production