Our team will conduct a comprehensive review of your current Quality Management System to identify gaps and deficiencies that need to be addressed to meet the requirements of Quality standards.

Development and implementation of a Quality Management System in compliance with ISO 13485 and/or ISO 9001, that grows with your organization.

Internal and supplier audits to ensure that the Quality Management System operates effectively and efficiently.

Development of a regulatory strategy that aligns with your business objectives and goals. Identification of applicable regulatory requirements, device classification and development of a roadmap to ensure compliance.

Hazard analysis, design FMEA, process FMEA, software, cybersecurity and use-related risk analysis in compliance with ISO 14971 and applicable product standards.