Gap analysis and internal status audits

The initial situation must be known at the start of a project. This is the only way to assure an efficient planning and implementation! Axxos supports you with preparatory audits, as-is or gap analyses.

Status audits, as-is or gap analyses are carried out at Axxos by IRCA-certified lead auditors and subject matter experts. Regardless of the requirements, be it ISO 13485, regulatory requirements of the FDA, MDR or MepV or other specifications (e.g. MDSAP) – Axxos draws a clear picture of the current status and the path to successful implementation of the requirements.

Quality Management Services
Regulatory Affairs
MDR Technical Documentation
FDA Services
FDA Submissions
Healthcare facilities
Update service standards and regulations