Regulatory Support

Our in-house regulatory and quality system expertise helps ensure your worldwide success.

  • Regulatory requirements and strategies are defined early in the product life cycle.
  • Ongoing regulatory/quality oversight at all stages of the project.
  • ERI’s quality system is certified to ISO 9001: 2000 and ISO 13485:2003, the worldwide standard.
  • Successful regulatory submissions including 510(k), CE mark, and Canadian device license.
  • Value-added clinical study design and management.
  • Assistance in building or improving your company’s quality system.