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AKQS provides Quality & Regulatory assistance to the biotechnology sector.

We specialise in helping small innovative firms with Quality and Regulatory issues, allowing scientists to concentrate on science, and business leaders to concentrate on business.

We assist with;

  • Conformity assessment routes
  • CE marking
  • Technical File preparation
  • ISO13485 certification
  • Quality System development
  • ISO13485 training
  • Audit preparation
  • Foreign market registrations
  • UK Responsible Person (authorised representative)
  • MDR /IVDR preparation
  • Brexit preparation
  • Risk Management
  • Health & Safety