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 (CFR, FDA)
  • Arab Nations (Saudi Arabia, Oman, Qatar, Turkey, UAE)
  • Australia & New Zealand
  • South America
  • Asia
  • 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, ISO 60601)