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Explore Our Specialized Consultation Services Tailored to System, Product, People and Services – Where Innovation Meets Expertise.

Our Consulting Services

product

  • Regulatory affairs

  • Development

  • Technical Documentation

  • Software as a medical device

  • Clinical affairs

  • World wide registrations

PRODUCT

services

  • EU/ CH/ UK- Representative

  • Complaint handling/monitoring

  • CAPA Management

  • PMS Management

  • Regulatory Monitor

SERVICES

system

  • Compliance strategy

  • Quality Management System (QMS)

  • KPI Management

  • NC, COMP, CAPA Management

  • Supply Chain Compliance

  • Manufacturing

  • Validation

  • Auditing Services 

SYSTEM

people

  • QMR

  • PRRC/FvP

  • QA, QP

  • Medical Device Advisor

  • Project management

  • Process execution

  • Service Management & Operation

PEOPLE

  • Strategy

  • Quality in Leadership

  • Leadership resonsibilities

  • Business developement

  • Strategic Interfaces

  • Outsourcing

C-Level

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