Gap Analysis and Assessment
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.
Quality Management System Implementation
Development and implementation of a Quality Management System in compliance with ISO 13485 and/or ISO 9001, that grows with your organization.
Supplier and Internal Auditing
Internal and supplier audits to ensure that the Quality Management System operates effectively and efficiently.
Regulatory Strategy and Planning
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.