Brightwake Regulatory Assistance

Regulatory assistance

 

Brightwake can offer assistance and guidance on the requirements for product classification and registration, along with the development of documentation to support compliance with regulatory requirements.

Brightwake has experience of obtaining regulatory approvals in:
  • European Union
  • United States of America
  • Arab Nations (Saudi Arabia, Oman, Qatar, Turkey, UAE)
  • Australia & New Zealand
  • South America
  • Asia
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Brightwake is able to support:
  • Notified Body interactions and certification
  • Novel device registrations & classifications
  • Good Manufacturing Practise
  • Good Laboratory Practise
  • Quality Management System & Regulatory Integration (ISO13485, ISO14971, ISO 60601)
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Brightwake research and development

R&D

Design, prototype manufacturing and development
 


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Brightwake manufacturing

Manufacturing

Full-scale manufacturing facility
 



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Brightwake regulatory approval

Regulatory

Getting your products from concept to full regulatory approval


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Brightwake distribution

Distribution

Global distribution networks


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