Brightwake Services

Services

 

Brighwakes services include

  • Contract manufacturing
  • Design consultancy
  • Clean room contract manufacturing (6 x Class 8)
  • Production engineering

 

  • Production process Design
  • Materials selection
  • Technical textiles
  • Regulatory assistance

 

  • Intellectual property development
  • Packaging and Logistics
  • Bespoke machine building

Regulatory assistance

Brightwake offers a global regulatory consultation service. With experience of Global Markets, the team can offer practical guidance on regulatory strategy and news. Some members of the team play a key role in regulatory revision in Europe and sit on a number of Technical Committees writing International Standards.
 
  • Key regulatory areas include:
  • European Medical Device (CE)
  • United States regulation (FDA)
  • Arab Nations (Saudi Arabia, Oman, Qatar, Turkey, UAE)
  • Australia & New Zealand
  • South America
  • Asia (CFD)
  • Korea
  • Notified Bodies & certification
  • Audit policy (internal, external)
  • Novel device registrations & classifications
  • Good Manufacturing Practise
  • Good Laboratory Practise
  • Quality Management System & Regulatory Integration (ISO9001, ISO13485, ISO14971, ISO60601
R&D Learn More
Brightwake research and development

R&D

Design, prototype manufacturing and development
 


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Manufacturing Learn More
Brightwake manufacturing

Manufacturing

Full-scale manufacturing facility
 



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Regulatory Learn More
Brightwake regulatory approval

Regulatory

Getting your products from concept to full regulatory approval


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Distribution Learn More
Brightwake distribution

Distribution

Global distribution networks


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