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Medical Device Consulting

"Quality is never an accident; It is always the result of
high intention, sincere effort, intelligent direction and skillful execution; It represents the wise choice of many alternatives"

Our Services

Medical Device Consulting

quality

  • QMS/eQMS Implementation and/or Management

  • Risk Management

  • CAPAs

  • Training

  • Audit Execution (MDSAP,        EU MDR, ISO 13485:2016, QMSR, Sterilization, etc.), 

  • AS 9100D, ISO/IEC17025

REGULATORY

  • Strategies

  • Submissions

  • Remediation

  • Compliance

  • EU MDR and QMSR Transitions

  • Pre-due Diligence Review

technical services

  • Technical writing

  • Validation, Verification and Qualification Plans

  • Statistical Analyses

  • Test Laboratory Sourcing

clinical

  • Site Qualification

  • Site Monitoring

  • Study Audits

  • TMF/eTMF Preparation and Maintenance

project management

  • Project Planning

  • Plan Execution

  • Resource Allocation and Management

PROGRAMS

  • Mentoring

Our Therapeutic Expertise

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  • Ophthalmic

  • Radiology

  • Cardiovascular

  • Gastroenterology/   Urology

  • Orthopedic

  • Neurology

  • Dental

  • Software as a Medical Device

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© 2025 by Rallis-Daw Consulting LLC

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