Services

EFFECTUM MEDICAL facilitates an efficient, accelerated market access for Medtech innovators by offering a maintained Plug-and-play Quality Management System and when needed, acting as legal manufacturer. Our new Plug-and-play QMS 2.0 is based on a modular concept where you can pick and chose the services that you require.

Through Effectum CH-REP, a company of Effectum Medical, we give companies domiciled outside of Switzerland access to the Swiss market by acting as their Swiss Authorized representative.

 

Plug-and-Play QMS 2.0
Service Overview
Effectum CH-REP your
Swiss Authorized Representative

 

Throughout each project phase we provide a variety of services. Not only Startups, but also R&D, Regulatory Affairs and Quality Management teams of established MedTech Companies can count on us as an external service provider.

#0

Kick-off

pre-project phase

  • Regulatory Opinion
  • Basic training on QMS
  • Workshop / Training Sessions

  • Project Management
  • Training & coaching

#1

Design
Input
Require­ments


Design & Development

  • Engineering
  • Technical Documentation
  • Independent reviewer
  • Supplier evaluation & selection

  • Project Management
  • Access to EM-QMS – for incubators
  • Access to EM-QMS – All-in
  • Shared norms & standards
  • Training & coaching

#2

Design
Freeze

#3

Design
Trans­fer


Industrialization

  • Shared re-processing validation
  • Supplier audits
  • Supplier management
  • Verification & Validation

#4

Verifi­cation &
Vali­dation

#5

Decla­ration of Confor­mity




product launch / post-market phase

  • Legal Manufacturer
  • Post Market Surveillance
  • Product management