Author: Liz Streeter
Liz Streeter is a quality assurance and regulatory affairs consultant who advises on manufacturing, testing and streamlining. She builds operational systems and frameworks to ISO 13485 and 9001 standards.

Notified Bodies: Choice or Controversy?

This jumble of names in the adjacent picture is a bit how one feels when first looking for a Notified Body. Who to pick?  How to discern one from the other? To a new company who is just starting down

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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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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
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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
Find Liz On LinkedinFind Us On Twitter