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Regulatory and Clinical Services

Avoid getting lost in the jungle of guidelines, standards and regulations by working with ROWIAK, an experienced guide in the field of medical devices and clinical trial management.

ROWIAK has more than five years of experience in the clinical trial management of medical devices. We offer customized know-how and will guide you directly to your personal goal. Because: detours cost money and use up valuable resources.

We support you throughout the whole regulatory legal process. Here’s an overview of our Regulatory Affairs and Clinical Services:

Clinical Trial Management: from Product Idea to Clinical Data

We offer:

  • Support in designing test plans, test protocols (CRF) and auditor brochures
  • Creation of Trial Master Files and Investigator Site Files
  • Support of the monitoring process before and during trials, including monitoring manuals
  • Selections and recommendations for qualified clinical trial sites and investigators

Technical Certification

To create your technical documentation efficiently we offer you our support and customized templates; e.g.

  • Risk Management File
  • Instructions and Manuals
  • Verification Test plans and protocols
  • Support during your standardized SEB and EMC tests (e.g. DIN EN ISO 60601-1 3rd ed.)

Contract Management

Correspondence and communication with the relevant authorities such as:

  • BfArM or correspondending European Authorities
  • Ethics Committee
  • Patient Insurance Companies

as well as support for the preaparation of contracts with clinical sites.


Mediation of Competent Contact or Cooperation Partners

In the case that we meet our limits, we will network with our partners or look for appropriate partners that will fulfill your requirements. These are companies or organizations are specialized in the specific fields of:

  • Clinical Evaluation
  • Monitoring / Clinical Research Associate (CRA)
  • Data Management
  • Biometrics

Experience and Advice

Furthermore, we offer experience and advice in all matters related to clinical testing and approval process and give you tips on how to avoid pitfalls.

We share with you the approval procedures for CE certification according to Directive 93/42/EEC.

As a partner during your company's application for DIN EN ISO 13485 certification, we can explain the main possible structure of your quality management system and can guide you through your first internal audit.

If we have roused your interest do not hesitate to contact us!

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Contact

Dr. Sandra Thorén
Clinical Data Management
Phone +49 (0)511 277 2960
Fax +49 (0)511 277 2959
s.thoren(at)rowiak.de

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