Quality & Regulatory

Quality Assurance
& Regulatory Affairs

Qity offers comprehensive Quality and regulatory services for Healthcare companies in accordance with ISO 13485, ISO 9001, ISO 14971, and IEC 60601, IEC 61010 and IEC 62304.

Our team of experts is dedicated to helping you achieve your quality objectives and meet the regulatory requirements. We are committed to providing our clients with the highest quality service from the proof-of-concept to the commercialization and delivering results that exceed expectations.

If you are looking for a trusted partner to help you achieve ISO 13485 certification, we invite you to contact us today to learn more about our services and how we can help you achieve your quality objectives.
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Portfolio

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

Quality Assurance & Regulatory Affairs

Portfolio

Gap Analysis and Assessment

Quality Management System Implementation

Supplier and Internal Auditing

Regulatory Strategy and Planning

Risk Management

Quality Assurance
& Regulatory Affairs