What sets CCS apart from other companies?

• We are able to simplify submission review cycles based on our knowledge of FDA requirements and experience in packaging. Our understanding of expectations can significantly reduce time to market
• Our personnel are trained experts in the technical and regulatory requirements for medical device and pharmaceutical companies
• We leverage our proven libraries of quality system procedures, design control specifications, and process validation protocols to simplify compliance solutions

Our specialties include:

• Design control compliance and validation of medical devices
• Safety risk analysis and safety risk management
• Manufacturing process validation
• Establishing quality systems
• Validation of manufacturing and quality system software such as LIMS and ERP systems
• Preparation of 510(k) and PMA submissions
• Quality system audits that integrate industry best practice recommendations
• Regulatory and industry best practice training
• Regulatory consulting for compliance with FDA regulations and conformance to ISO standards
• And many more, including Part 11 compliance, IVD and IVDMIA, MDDS, wireless connectivity, test method validation, ERP validation.