Quality Management System

Unlocking Quality Excellence: QMS 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: A strong Quality Management System (QMS) is essential for regulatory compliance.Robust documentation is the cornerstone of a successful QMS. We assist in the development and optimization of Standard Operating Procedures (SOPs), quality manuals, risk policies, and other essential documents to streamline processes and facilitate compliance.
  
  
• QMS Implementation and Optimization: Quality System Implementation: We understand that each medical device company has unique requirements. Our expert consultants work closely with your team to design, implement, and optimize a customized QMS that aligns seamlessly with your business objectives and regulatory obligations.
  
  
• Training and Education: Empowering your team with the knowledge and skills necessary to uphold quality standards is integral to QMS success. We offer tailored trainings on QMS principles, regulatory requirements, and best practices to foster a culture of quality throughout your organization.
  
  
• Internal Audits and Gap Analysis: Proactive assessment is key to identifying areas for improvement within your QMS. Our experienced team conduct thorough internal audits and gap analyses to pinpoint areas of non-conformance and implement corrective actions, ensuring continuous improvement.
  
  
• Supplier Qualification, Evaluation and Audits: Our experienced auditors conduct thorough assessments of potential suppliers to ensure they meet your company's quality standards and regulatory requirements. We evaluate supplier capabilities, processes, and quality management systems to identify any risks or gaps that may impact product quality or regulatory compliance. For existing suppliers, we perform regular audits to monitor and evaluate their performance over time. Our audits focus on key quality metrics, adherence to specifications, delivery reliability, and responsiveness to corrective actions. By proactively assessing supplier performance, we help you maintain a robust supply chain and minimize disruptions. We assist in identifying and addressing any non-compliance issues to maintain regulatory conformance across your supply chain.
  
  
• Customized Audit Reports and Action Plans: Following each audit, we provide detailed reports outlining audit findings, observations, and recommendations for improvement. Our reports are customized to your company's specific requirements and include actionable insights to help you address identified issues and drive continuous improvement in supplier quality and performance.
  
  
• Regulatory Compliance and QMS certification : Navigating the complex regulatory landscape can be daunting. Our seasoned professionals provide guidance and support to ensure QMS compliance with global regulations and standards such as MDR, FDA, MDSAP, and ISO 13485. From documentation to certification audits, we have you covered.