Medical Devices

We offer you:

  • Tests / GLP / registration
  • Contract Research Services
  • Regulatory Services
  • In vitro-tests
  • Project Management
  • Study Monitoring
  • Preparing and updating of Material Safety Data Sheets
  • Outsourcing Services

 

Dear customer,

INVITRO-CONNECT GmbH offers you a full range service for the registration of your Medical Devices according to the European Regulation EN ISO 10993.

The tests are usually carried out according the OECD-guidelines and under GLP (Good Laboratory Practice) in an accredited test laboratory.

Furthermore we are offering you a complete outsourcing package for all your tests and studies.

Medical products

From the development of an excellent test strategy, over the project and laboratory coordination to study monitoring, toxicological expertise and GLP inspections at the affiliated laboratories.

Benefit from our wide range of expertise, our experienced collaborators and an international well established network of partners: thoroughly selected experts, toxicologists and more than 80 accredited testing laboratories with an over 20 years’ track record in the industry.

INVITRO-CONNECT GmbH puts together the right team for each project. Thanks to our familiarity with the laboratories and the experts, we commission those most suited for the specific service. That way we can guarantee high-quality results.

We provide final test reports including the registration dossier, of course in the format of your choice, digital as well as on paper and worldwide.

We fully advise and support you with our expertise and the expertise from our whole global cooperation network.

We offer you all tests and services with the best price-performance ratio.

We are happy to also be your service provider and support your projects reliably –as we already do for many other satisfied clients.

For further information or interest in collaboration with us please do not hesitate to contact us personally. We are pleased to be of service to you.

Tests according GLP and for registration

  • ISO 10993-3: Genotoxicity, carcinogenicity and reproductive toxicity
  • ISO 10993-4: Selection of tests for interaction with blood
  • ISO 10993-5: Tests for in vitro cytotoxicity
  • ISO 10993-6: Tests for local effects after implantation
  • ISO 10993-7: Ethylene oxide sterilization residuals
  • ISO 10993-10: Tests for irritation and skin sensitization
  • ISO 10993-11: Tests for systemic toxicity
INVITRO CONNECT GmbH