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
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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Getting your products from concept to full regulatory approval

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