Regulatory and Quality System 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.

  • Evergreen Research’s quality system is certified to ISO 9001: 2015 and ISO 13485:2016, the worldwide standard.

  • Successful regulatory submissions including 510(k), CE mark, and Health Canada Certification.

  • Value-added clinical study design and management.

  • Assistance in building or improving your company’s quality system.

  • Independent verification and validation.

See how ArcScan incorporated our Product Development and Regulatory Services in this recent case study.