Quality & Regulatory

Cobalt has experience and expertise in a broad range of quality system activities and regulatory affair services. At Cobalt we can support your company from product design and development through clinical trials.

Cobalt's expertise is in the following areas:

• Customizing a quality system to meet your specific company needs
• Development of procedures and processes to support your project
• Regulatory submission support, including drafting of submissions
• Document control through all phases of research, development, sales
• Complete documentation packages including:
  
  
  • Design History Files
  • Device Master Records