Menü überspringen
Menü überspringen
icon_regulatrory-services

Regulatory Services

Quinn Healthcare assist manufacturers with their regulatory processes. They clarify the numerous requirements of European directives and regulations for in vitro diagnostics and medical devices, propose practical solutions to meet them, and/or prepare your technical documentation and design dossiers. We also consider your international orientation outside Europe.

Among other things, we offer assistance with:

  • Selection process of a Notified Body

  • Support with IVD directives and IVD regulations

  • CE approval process

  • Technical Documentation

Get in touch now

Do you have questions about one of our services, or would you like to explain your project in a personal meeting? Then feel free to contact us directly here.

Request a callback Send us a message

Our Services

icon_studienmanagement

Study Management

Support in the complete performance evaluation of your product in the field of In-vitro-Diagnostics according to the new IVDR regulations.

read more
icon_performance-studies

Performance Studies for IVDR

Holistic support for validation, performance testing and documentation of your In-vitro-Diagnostic devices according to the new IVDR

Read more
icon_supply-chain-distribution-management

Supply Chain & Distribution Management

Offer of broad services in the area of logistics, warehousing and distribution of your products

Read more
icon_kommerzialisierung

Commercialization

Consulting and implementation of individually designed sales and marketing strategies, as well as the establishment of a European distributor network or own distribution

Read more