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!

 

 

 

 

 

Services

 

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

 

Product Design and Development Design for manufacture and assembly

 

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

Devices risk management
Nutrition
Legal Apostille
Legalisation of documents
Global Embassy Representative
Patent advice, patents and Intellectual Property services

 

 

 

Contact  

 

Head Office

 

OpenWater International Ltd

Unit D,

Otehall Farm Busines Park,

Janes Lane,

Burgess Hill,

West Sussex,

England

RH15 0SR

 

Tel 01495 790614

Email info@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