Tag: IOS 13485

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

Posted in Quality Assurance Tagged with: , , , , ,

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
Find Me On LinkedinFind Us On Twitter

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
Find Liz On LinkedinFind Us On Twitter