Services

EFFECTUM MEDICAL supports innovators in realizing their ideas, establishing sustainable businesses and to reach a successful exit. We provide an outsourced Quality Management System which our customers use to document their development, and market their Medical Devices. Offering all needed competencies, we can act as legal manufacturer and provide our clients with a lean product registration as well as engineering services. For each project phase we offer a variety of matching 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