With over 100 years of collective team experience, CRQA stands at the forefront of the medical devices and healthcare industry. Our team expertise spans across manufacturing operations, supplier quality management, product/process development, and especially, Quality Management Systems (QMS) assessments. CRQA’s efficiency in delivering operational excellence and our deep knowledge in regulatory standards positions us as an unparalleled consultant for your medical device projects.

• Medical Device Consultancy: We conduct thorough audits of your quality management system (QMS) against the requirements of ISO 13485, identifying potential gaps and non-conformances.
• Quality Management Systems (QMS) Services: Our team consists of certified and industry-recognized auditors with extensive experience in the medical device industry.

• Diverse Industry Exposure: Deep understanding of the medical devices value chain, with proven success in manufacturing, quality assurance, and business development roles.
• Strategic Leadership: Team has proven track record of establishing and optimizing operations for medical device companies, leading to accelerated growth and operational excellence.
• Global Expertise: Extensive experience in international markets, offering a global perspective on business expansion and compliance strategies.
• Comprehensive Training and Certifications: Our team of medical device experts are backed by rigorous training and certifications in QMS, project management, and leadership, ensuring up-to-date knowledge and best practices.

CRQA is dedicated to helping your organization achieve its goals through strategic consultancy, operational improvements, and quality management excellence. Our approach is focused on integrating quality into every aspect of the product lifecycle, from development through to market delivery, ensuring not just compliance, but a competitive edge in the global market.