GHP Healthcare and Pharmaceutical Global Award



Best Medical Device Manufacturing Consultancy UK


Openwater International Ltd

OpenWater is a global award winning 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.




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 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!









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


Hydrocolloid Formulation and manufacture  
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  
  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


Dependent on the client’s regulatory pathway we can design and supply all the required Quality Management System documentation. We can create this around any industry preferred standard. The most common standard globally for medical devices is 13485, but 9001 is also acceptable as is any other Quality Management System of the client’s choice


We design the Quality Manual  which illustrates the structure and function of all personnel and processes within the business that are associated with the Quality  of the product.  This can be supplied to anyone in the supply chain as a marketing tool and for conformity assessment activities including audits, certification and global marketing applications


We include all record templates,  procedures and processes required to satisfy compliance requirements in more than 85 countries

  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  
  Person responsible for regulatory affairs   
  ISO Certification   
  13485, 9001, 14971, 60601, 10993, (EU) 2017/745, 3071/746, CFR 820  
  Global Competent Authority Representative  

Devices risk management 


Risk management of medical devices is critical to determine all compliance requirements are implemented, during research and development, during the production stage and post market. It therefore includes all design and production process changes as regulatory pathways are determined, mapped and implemented


The Risk Management Process from OpenWater is based on ISO 14971 -  Application of Risk Management to Medical Devices or any other relevant technical industry standard of your choice


OpenWater’s Risk Management Process includes the following elements with regard to Class I medical devices


Risk analysis, risk evaluation, risk control, risk verification, risk evaluation, overall residual risk evaluation and production and post production information


Risk Identification

OpenWater’s Risk Identification includes the identification of hazards for Safety, Product Realisation,  General Safety,  Biological Hazards  and Post Market Surveillance


What We Supply

We supply the Risk Management Procedure and all documentation including a final Risk Management Report that is compliant with the regulatory requirements of more than 86 countries


Risk Management Training

OpenWater can supply training to satisfy Quality Management System training requirements that includes video call support to complete the paperwork and all risk associated tasks

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




Evidence based Clinical Nutrition from Patient Healthcare Coach in Chronic Disease Reversal and Lifestyle Medicine - Certified by T Colin Campbell Center for Nutrition Studies 


Supporting patients and users to help patients live life better with the everyday management of medical devices 




Head Office


OpenWater International Ltd

Unit D,

Otehall Farm Busines Park,

Janes Lane,

Burgess Hill,

West Sussex,


RH15 0SR


Tel +44 (0)7704 426 371



Registered Office 


OpenWater International Ltd

The Manse Station Road,

Plumpton Green, Lewes,

East Sussex,




11250848 Registered in England & Wales