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Services

Keathley and Company offers a range of management consulting services for healthcare related organizations.  Based on her experiences across medical device software development, clinical research, and biopharmaceutical manufacturing, Jane Keathley can help you establish and optimize your quality management system, including operations processes and regulatory and standards compliance, with a focus on overall performance improvement.

 

Management System Development

  • Gap analysis; implementation, planning, and execution
  • FDA regulations, NIST Cybersecurity Framework 
  • ISO standards, Baldrige criteria
  • Auditing (regulatory and standards compliance)
  • Case studies
 

Product Quality and Innovation Management

  • Product risk management
  • Product quality assurance
  • Innovation process and tools
  • Case studies
 

Training and Professional Communications