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OPENWATER is a complete Manufacturing and Quality Assurance/Regulatory Affairs Consultancy specialising in, but not confined to, Medical Device Manufacture and the components related to that industry.
OPENWATER is Nick Shelley and Liz Streeter.
Nick Shelley is the Manufacturing Consultant who can advise on all aspects of design, materials, machinery, tooling, processes, factory layout and work flow, value engineering.
Liz Streeter is the Quality Assurance/Regulatory Affairs Consultant with much experience of installing quality systems to ISO 13485 and ISO 9001 and working with both European CE marking regulations and FDA requirements. Liz has also worked with service industries.
We have 50 years combined knowledge and have built up access to a wide distribution network by supplying consultancy services to the international market.
OPENWATER is a unique combination of two sets of skills that compliment each other to provide the client with the complete ability to take a concept for a new product right through to full realisation and placement on the market.
A large part of our experience has been in high margin, single use, wound care and ostomy manufacture, including the formulation and manufacture of hydrocolloid.
We are expert in assisting with start up projects and specialist help for small businesses, where we have strength and experience in bringing a small company's products from the design stage into full production. We install full quality assurance systems and set up all associated regulatory requirements, and can provide machinery design.
If you are a medium or large company needing a particular project completed or need to call in some specialists for a while, we are happy to help.
We will give you no nonsense and sound advice and won't waste your time.
We are happy to roll up our sleeves and join you on the shop floor to make product, design equipment and train staff.
.......FROM CONCEPT TO MARKET........ PLAIN SAILING WITH OPENWATER
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