Rallis Consulting LLC offers consulting support at varying levels of experience. Consultants on staff hold current certifications including but not limited to:

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  • American Society of Quality (ASQ) Certified Quality Engineer (CQE)

  • ASQ Certified Biomedical Auditor (CBA)*

  • Regulatory Affairs Certification (RAC) Devices

  • Exemplar Global Certified Medical Device (ISO 13485:2016) Lead Auditor

  • Exemplar Global Certified EU MDR Lead Auditor

  • Exemplar Global Certified Regulatory Compliance Lead Auditor

       * Now known as Certified Medical Device Auditor (CMDA)

 

 

Certifications currently in the works:

  • Association of Clinical Professional (ACRP) Certified Clinical Research Associate (CCRA)

  • ASQ Certified Manager of Quality and Operational Excellence (CQM/OE)​

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PROFESSIONAL AFFILIATIONS

Consultants on staff are members of the following professional organizations:

- American Society of Quality (ASQ)

- Society of Women Engineers (SWE)

- Association of Clinical Research Professionals (ACRP)

- Regulatory Affairs Professional (RAPS)

- Orange County Regulatory Affairs (OCRA)

- Device Alliance

- International Society of Female Professionals - Member

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STRATEGICALLY STRONG, YET TACTICALLY SHARP