Medical Device Validation Services

Computer assisted bone remodelling studies help prosthetic manufacturers target their product designs on particular clinical needs. Optimisation and remodelling analysis is available through MET combined with: clinical model development, FE analysis, bone density mapping, loading analysis and remodelling studies. All this leads to optimisation of geometric designs, surface features, porosity and all the details of the implant.

Material selection is a crucial element in the early stages of developing a new product. Confidence in the performance properties and storage stability is essential to allow a project to proceed efficiently. MET's environmental chambers are used by clients to provide accelerated ageing for materials which are then tested in our laboratory. We can compare properties for fresh product and aged product to provide the design inputs to move your projects forward.

Efficiency can be hard to achieve when packing medical devices into blisters. When production rates are not high many manufacturers source pre-formed blister trays externally. Lead times can be long and minimum order quantities high. In addition detailed incoming inspection is required as trays can be distorted in transport and storage and hence become more difficult to seal.

 When using the RAMAC combined tray former/sealer trays are produced on demand. This reduces the opportunity for distortion; the storage space required and inventory costs. Typically 5,000 flat sheets of rigid PETG for forming 100mm square trays might cost 250 Euro and be available within a few days. Quality goes up and costs go down, perfect.

As part of our 'excellence in medical device testing' programme MET has published an article on Endovascular Device Testing. This article will be useful to development engineers, QA engineers and regulatory professionals. It is published in the May edition of European Medical Device Technology.

The article can be found here.

MET's first priority for blister lid sealing is the seal quality. We specify only the most rigid and robust medical tray sealers. For situations requiring efficient production we are now supplying the RAMAC combined tray forming / lid sealing machine.

The RAMAC 525 work station provides an efficient platform for packing: components, orthopaedics, kits, instruments, catheters and much more. The forming tools are liquid cooled, with vacuum and air plug forming techniques. The sealing tools deliver top quality seals and the PLC retains a large number of programmes to give that extra flexibility.

No need to stock a wide range of blister trays. Forming tool changes on the RAMAC 525 are completed in just a couple of minutes.

Lid-stock and tray forming materials are available from MET also.

For more information, please use our contacts page to request a call back.