Services

In the dynamic landscape of medical device innovation, ensuring and maintaining regulatory and quality compliance is paramount. At citoQualis, we specialize in providing comprehensive Quality Management System (QMS) services tailored specifically for medical device companies.

• QMS Set-up - Documentation and SOP Development
• QMS Implementation and Optimization: Quality System Implementation
• Training and Education
• Internal Audits and Gap Analysis
• Supplier Qualification, Evaluation and Audits
• Customized Audit Reports and Action Plans
• Regulatory Compliance and QMS certification

Accurate and comprehensive technical documentation is fundamental to regulatory approval. Our experts carefully prepare and maintain technical files, including all required documents such as design specifications, verification and validation plans and reports, to support regulatory submissions and demonstrate product compliance.

• Design and development
• Risk Management
• Clinical Evaluation
• Biological Evaluation
• Usability Engineering

Effective training and education are essential for the success of medical device manufacturers in a constantly evolving industry. That's why we offer tailored training and education programs designed to meet the specific needs of medical device manufacturers.