The client is an India based fast growing medical devices company. The client approached Freyr for Regulatory support with carrying out audits for its manufacturing facility, Quality Management System (QMS) remediation and Standard Operating Procedure (SOP) rationalization. Since the client was ISO 13485:2003 certified, the challenge was to upgrade the organization to ISO 13485:2016 standards.

Read the case to know how Freyr managed to complete the project within two weeks and prepare the client for audit-readiness.