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Our Consulting 

Services

Explore Our Specialized Consultation Services Tailored to System, Product, 

People and Services – Where Innovation Meets Expertise.


5 Pillars, the core of our Services!

SYSTEM












PRODUCT

  • Regulatory affairs
  • Developement
  • Technical Documentation
  • Software as a medical device
  • Clinical affairs
  • Usabillity
  • Risk management
  • Worldwide registrations

PEOPLE

  • QMR
  • PRRC/ FvP
  • QA, QP
  • Medical device advisor
  • Process execution
  • Project management
  • Service management & operation
  • Upskilling workshops

SERVICES

  • EU/ CH / UK- Rep
  • Complaint handling/ monitoring
  • CAPA Management
  • PMS Management
  • Regulatory monitor
  • Holiday Service
  • IT / ITIL
  • Infrastructure support

C-LEVEL

  • Strategy
  • Quality in Leadership
  • Leadership responsibility
  • Buisness developement
  • Outsourcing

Special services for:

STARTUPS


  • Understanding the MedTech world
  • Understanding the regulatory requirements
  • Right decisions in every stage of a start up
  • Start up live cycle
  • Buisness & regulatory strategy
  • Marketing & Sales strategy
  • Scale up

SUPPLIER


  • Exhibition support
  • Sales training
  • Sales support
  • Sales workshop
    • Understanding the Medtech world
    • Understanding regulatory requirements
    • How to use regulatory requirements for sales
    • Understanding your client
    • Counterarguments

DISTRIBUTOR


  • GDP Readiness
  • Regulatory requirements
  • EU/CH-REP obligations and responsibilities and set up
  • Importer obligations and set up
  • Supplier qualification and monitoring
  • Auditing
  • Communication with authorities
  • Go to market strategy

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