Tag: manufacturing

Assessing your manufacturing operations – from the customer perspective

A lot of consultants will audit your company and come up with a long list of opportunities for improvements, and if you follow their advice you will conceivably make your manufacturing operations very much more efficient. You might also end up

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Customer Supplier Partnerships – a collaborative relationship

Once upon a time I was asked to set out a strategy for improving supply chain management with the objective to reduce our reliance on some key suppliers whose products were considered to be of such a specialised nature as

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Is the patent process still worth it?
Protecting your IP – Part 1

Invent something clever and potentially lucrative then protect it via a patent. This was the time honoured way, and is still usually the only way to safeguard your idea, to stop someone else from benefiting from it. But things are

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The Perception of Quality Management Standards: ISO 13485 – a good way of looking at it

To a small business, just starting out, it does always seem a very daunting thing to install a Quality Management system to ISO 13485 or ISO 9001. As I am generally more involved with medical device manufacturers and those businesses

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How to build manufacturing into your medical device designs

“If medical companies want to continue to make money as prices face continued pressure , their only option is to take cost out.’’ This comment is from the head of procurement of a major UK healthcare provider. Everywhere in the

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Welcome to the Open Water blog

Thanks for stopping by. This blog will be regularly updated with our thoughts relating to the medical devices industry, manufacturing and devices consultancy in general. Check back for more later!

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Who we are:

OpenWater is Nick Shelley and Liz Streeter. With a combined experience of over 50 years in medical device manufacture, we help companies succeed by offering specialist knowledge and expertise to get their products to market. Working hands on with our clients, we get actively involved in the manufacturing process for the best possible results. Very aware of changing markets and world medical device price pressures, we understand the need to combine innovation with responsible manufacturing, regulatory costs and long-term efficiency.

Nick Shelley

medical device consultantManufacturing Consultant Nick Shelley advises on all aspects of design, materials, machinery, tooling, processes, factory layout, work flow, and value engineering. He has been working in these areas for over 30 years.

Tel: 0044 (0)7704 426371
Email: nickshelley@openwater.uk.com
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Liz Streeter

quality assurance consultantQuality Assurance/ Regulatory Affairs Consultant Liz Streeter builds operational systems and frameworks, and advises on manufacturing, testing and streamlining - all with a mind to meeting business goals. She has extensive experience installing quality systems to ISO 13485 and ISO 9001, working with both European CE marking regulations and FDA requirements.

Tel: 0044 (0) 7778 317806
Email: lizstreeter@openwater.uk.com
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