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.