Medical Device Consultants | Medical Engineering Consultants

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Medical Engineering Consultants Services Options

Our commitment to retain and grow talent has been key to our ongoing success. This has enabled Medical Engineering Consultants (MEC) to continue to strengthen our internal and external training and support systems which further embeds the culture of excellence within the organization.

When a MEC resource commences a project, they bring this culture of excellence and MEC’s entire body of experience to our clients. Every MEC engineer has access to our full suite of internal resources from regulatory to project management. You are not just on-boarding a resource, you are on-boarding MEC’s guarantee of excellence.

Medical Engineering Consultants Services Options

AREAS OF EXPERTISe

QUALITY

  • Design Control
  • Risk Management
  • Quality Assurance
  • Design Assurance
  • Supplier Quality
  • Post Market Surveillance
  • CAPA
  • Quality Control

ENGINEERING

  • R&D
  • Process Development
  •  Sustaining
  • Line Support
  • Verification & Validation
  • Equipment Specification & Installation
  • Software Validation
  • Statistical Analysis

REGULATORY & COMPLIANCE

  • Auditing, Audit Preparation & Management
  • Regulatory Submissions
  • Inspection Readiness & Response Management
  • QMS Implementation & Remediation
  • EUMDR
  • MDSAP
  • HIPAA

OPERATIONAL EXCELLENCE IMPLEMENTATION

  • Forecasting & Planning
  • Purchasing
  • Incoming
  • Mechanical Test Labs
  • Testing Stations &
    Laboratories
  • Distribution

SCIENTIFIC

  • LIMS Specialists
  • Molecular Biology
  • Laboratory Analysts
  • Scientists
  • Technical Writing
  • Method Validation Specialists
  • Pharmacovigilance
  • Drug safety

TURNKEY PROJECTS

Medical Engineering Consultants projects on acquisitions, manufacturing, commercialization, and supplier management

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