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.