Quality Management System

  • Implementation and/or maintenance of a QMS meeting the requirements of EN ISO 13485:2016, ISO 9001:2015, 21 CFR Part 820 or MDSAP.

  • Validation covering devices and equipment.

  • Complaints and Recalls.

  • Support during QMS regulatory authority audits from preparation to execution to audit response.

  • Supplier audits.

  • Internal audits.

  • Mock inspections. 

  • Remediation programs.

  • Root Cause Analysis and CAPA.