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 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.

 

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

 

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

 

Nutrition

 

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 

 

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