Design of medical devices and instrumentation is not just about good design but a full understanding of risk management and the regulatory pathways. Without this knowledge the development of products can at best be delayed and at worst be defective. We have successfully developed Class III medical devices for clients producing the technical file and risk management reports necessary for registration. We work to the latest guidelines and standards to ensure that the developments can be CE marked for the global market. Because of the complex nature and the many disciplines involved we can provide a Project Management service where all information can be focused and communicated effectively amongst all parties.
One of the challenges facing the medical industry currently is providing cost effective solutions, especially within a global market and stringent reimbursement systems. This will become more challenging as health budgets are cut and authorities wish to see ‘value for money’. Medical products are generally complex to manufacture and require flexibility to run smaller batches with ‘personalised’ products. Together with rigorous quality controls and regulation this can significantly reduce manufacturing efficiencies. Fruition has worked with leading medical companies at all stages of the Process Development from ‘proof of principle’ fixturing to implementing Lean Manufacturing philosophies providing large cost savings to the client.
IVAN GREEN C. Eng MIMechE, MIET
Ivan Green founded the company in 1998 following successfully growing and leading other technology companies. Educated at the University of London winning awards for design he has worked in many aspects of product development from design to manufacture within a variety of industries.
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