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Qualomics, LLC

Contact:  Erica Livingston, President
Specialty: Devices, IVD

Quality Assurance and Regulatory Affairs consulting services for medical device developers and manufacturers. Having spent years at the bench as product development scientist, I bring an appreciation of Operations and the impact that Quality Systems and Regulatory requirements have on the bottom line. I specialize in pre-market activities such as Quality System development and improvement, audit preparation and remediation, ISO certification, process development, design control and validation.

  • Certified in ISO 13485:2016, ISO 14971:2012 and the MDSAP audit method.
  • Experience in orthopedics, IVDs, and combination products.
  • Proficient in CLIA, CAP Accreditation, LDTs and clinical operations
  • Class I and II submissions in EU, Canada, Australia and US

Years in business: 5 

 

Phone:     858-247-6804
Email:      This email address is being protected from spambots. You need JavaScript enabled to view it.
W
ebsite:  http://Qualomics.com