Horizon Phoenix Europe, Services

By: Horizon Phoenix Europe  05/12/2011
Keywords: audits

  • CE Marking / Testing / Certification
  • Authorized Representation in Europe/U.S.A.
  • Quality Assurance / Validation
  • Contract Manufacturing
  • Cleanroom Design

Complete List of Services:

  • Validation - Equipment, Process, Packaging, Sterilization & Computer
  • Attending ISO/EN Surveillance Audits
  • Attending Customer Audits
  • Maintaining quality system documentation
  • Revising/Amending Quality System documentation
  • Document Control & Issuance
  • Performing Internal Quality Audits
  • Assisting with FDA - 510(k) Approvals, PMAs
  • Assistance with Contract Reviews (regulatory compliance)
  • Assistance in acquiring CE marking approval
  • Telephone support on regulatory issues
  • Ongoing quality training for employees
  • Supplier/Vendor evaluation (on-site)
  • Adverse Event Reporting (Vigilance/Global)

Keywords: audits