Quality Assurance and Regulatory Compliance consulting company specializing in development, maintenance, and audit assessment of quality management systems and regulatory and standard compliance for medical device, biopharmaceutical, and aerospace industries. Particular expertise in assisting start-up and growing companies in achieving scaled solutions to achieving compliance and performance excellence.Christy Kowalewski, President, is a Quality Assurance and Regulatory Compliance leader leveraging over 20 years of experience in the development/implementation of holistic and compliant quality management systems and innovative solutions to drive compliance, improvement, and efficiency in areas of medical device, biopharmaceutical, and aerospace industries. Proven success in building and maintaining state of the art compliant and efficiently scaled quality system solutions for a wide variety of company sizes and business needs.SPECIALTIES:ISO 13485, ISO 900121CFR Parts 820, 210, 211ISO 9001, AS9100, AS9115, DO178, FAASoftware Validation; 21 CFR Part 11Quality System AuditsCorrective and Preventive Action / Root Cause InvestigationSupplier ManagementProduct Development Quality AssuranceTechnical FilesRisk ManagementMedical Device Sterilization Development and Execution of Quality and Regulatory Training ProgramsProcess Improvement / Process Mappinge-QMS Configuration and Validation (MasterControl)