GHP Healthcare and Pharmaceutical Award
Winners 2020!
Openwater International Limited
Best Medical Device Manufacturing Consultancy UK
https://www.ghp-news.com/issues/healthcare-pharmaceutical-awards-2020/106/
OpenWater is a manufacturing consultancy with its expertise in medical devices design, compliance and manufacture, from conception to market and, for the device lifecycle to disposal.
We get actively involved in plant design, validation, manufacturing processes, Quality Management Systems, compliance, regulatory strategies, marketing applications and, we work hands on with our clients to ensure the shortest lead times to market.
We are very aware of regulatory requirements and price pressures and, we understand the need to combine innovation with responsible manufacturing by adding value to your business
OpenWater International Ltd
OpenWater boasts a unique combination of skillsets that complement each other to provide clients with the complete ability to take a new product concept through to full realisation and market placement.
Our experience has been mainly focused on the devices industry, mostly in high margin, single use devices such as wound care, general surgical devices, ophthalmics and ostomy manufacture, including the formulation and manufacture of hydrocolloid.
We are expert in assisting Start Ups and we provide 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, advise on applicable regulatory requirements and, provide machinery design.
If you are a medium or large manufacturer with a particular project to be completed, or need to call in some specialists for a while, we are willing to help.
We are happy to roll up our sleeves and join you on the shop floor to make product, design equipment and train staff. We will give you no nonsense, sound knowledge to save you time and costs.
We can advise on all aspects of medical devices design, materials, machinery, tooling, processes, factory layout, work flow and value engineering.
We supply services in Regulatory Affairs and advise on all classes of medical devices design, management systems, global marketing compliance, marketing applications, tenders, legalistion of documents, due diligence and lean regulatory strategies.
Nick Shelley is the Manufacturing Consultant who advises on all aspects of medical devices design, materials, machinery, tooling, processes, factory layout, work flow and value engineering.
Get in touch today to find out how Nick can advise your company through every stage of the manufacturing process, to give you the freedom and confidence to expand without limits.
Email NickShelley@OpenWater.uk.com
Joanne Davies is the Lead Consultant in Regulatory Affairs and advises on all classes of medical devices design, compliance, Quality management systems, global marketing applications, tenders, legalistion of documents, due diligence and lean regulatory strategies.
Email JoanneDavies@OpenWater.uk com to ensure your route to market is efficient, compliant and the most cost effective. But above all, your devices are safe and effective for the patient and/or user and the environment.
At OpenWater we have more than sixty years of knowledge and diverse experience in the manufacturing world. We have built up access to a wide distribution network by supplying consultancy services to global markets.
... from concept to market ...
... plain sailing with OpenWater!

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Services
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| Factory | Manufacturing facility design layout | |
| Materials and manufacturing process selection | ||
| Tooling design | ||
| Process introduction | ||
| Planning and installation | ||
| Business continuity planning | ||
| Manufacturing data restructure | ||
| Production and process validation | ||
| Cleanroom | Design, build and validation | |
| Machinery | Small machinery design, build and validation |
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| Hydrocolloid | Formulation and manufacture | |
| Product Design and Development | Design for manufacture and assembly |
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| Product development process | ||
| Project management | ||
| Engineering drawings | ||
| Devices risk management | ||
| Technical documentation | ||
| CE marking | ||
| Raw Materials | Materials and manufacturing process selection | |
| Specifications | ||
| Biocompatibility studies | ||
| Supplier partnership and development | ||
| Processes | Quality Management System design | |
| Quality Management System implementation | ||
| Workflow and automation | ||
| Build or restructure | ||
| Quality Assurance | Quality Management Systems design and implementation | |
| Quality Management Systems audits | ||
| Proccedures and forms | ||
| Test report writing | ||
| QMS Representative | ||
| Notified body | ||
| Accelerated shelf life studies | ||
| Systems and software validation | ||
| Calibration systems and services | ||
| Regulatory Affairs | Regulatory strategy | |
| Interim management | ||
| Design dossier compliance review | ||
| Technical file compliance review | ||
| Global marketing applications and reviews | ||
| Notified body | ||
| Global marketing submissions | ||
| Tenders | ||
| Person responsible for regulatory affairs | ||
| ISO Certification | ||
| 13485, 9001, 14971, 60601, 10993, (EU) 2017/745, 3071/746, CFR 820 | ||
| Global Competent Authority Representative | ||
| Training |
Good manufacturing practice |
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| Devices risk management | ||
| Nutrition | Evidence based clinical nutrition from our qualified Patient | |
| Healthcare Coach in Chronic Disease Treatment and Lifestyle | ||
| Medicine to support patients and users with the every day | ||
| management of medical devices | ||
| Legal | Apostille | |
| Legalisation of documents | ||
| Global Embassy Representative | ||
| Patent advice, patents and Intellectual Property services | ||

Partners

Contact
Head Office
OpenWater International Ltd
Unit D,
Otehall Farm Busines Park,
Janes Lane,
Burgess Hill,
West Sussex,
England
RH15 0SR
Tel +44 (0)7704 426 371
Email Nickshelley@openwater.uk.com
Registered Office
OpenWater International Ltd
The Manse Station Road,
Plumpton Green, Lewes,
East Sussex,
England
BN7 3BX
11250848 Registered in England & Wales