quality manufactured devices

We provide complete quality assurance and regulatory affairs advice, for all device manufacturers.

At OpenWater, we will accompany you from concept to the market, by combining our two extensive skillsets: Nick Shelley, Manufacturing Consultant, can advise on all aspects of design, materials, machinery, tooling, processes, value engineering, factory layout and work flow. Liz Streeter, Quality Assurance / Regulatory Affairs Consultant, is an expert in installing quality systems to ISO 13485, working with both European CE marking regulations and FDA requirements.

We believe in empowering our clients, not lecturing or cajoling, and at whatever stage we join you our ultimate goal is to set you free on an unlimited ocean of success.

Our expertise lies in medical devices, with a large part of our experience concerning high margin, single use, wound care and ostomy manufacture, including the formulation and manufacture of hydrocolloid.

We provide specialist help to start-up projects and small and medium businesses, offering the industry knowledge and advice to take your products from the design stage through to full production. We ensure careful handling of quality assurance and associated regulatory requirements, and can provide additional machinery design help.

Whether you want a full course of guidance for your product or specialist knowledge on a specific point, we’ll offer solid no nonsense advice without wasting your time.

The level of our input is up to you – theoretical advice from a distance, or sleeves rolled-up joining you on the shop floor to make your product, design equipment and train staff – we’re comfortable in all areas of manufacturing.

Get in touch by phone or email to discuss your needs today.

From concept to market – plain sailing with OpenWater