Regulatory, Clinical & Quality Affairs for the MedTech Industry

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Design Management and Execution of Clinical Trials

Clinical studies are crucial to the process of bringing a new medical product to market.  Conducting a clinical trial in an ethical and appropriate manner is a key factor to ensuring a successful regulatory submission and later on, the sales process.  Services available include:

 

•   Consultation on Study Plans and design

•   Getting in contact with study sites and appropriate professionals (doctors, nurses)

•   Preparation of Study File- Informed consent, Investigator’s Brochure, Protocol, CRF etc.

​•   Submission to ethics committees or FDA Investigational Device Exemption (IDE)

•   Site evaluations

•   Training on Monitoring the Study

•   Assessing changes to study

•   Preparation of study reports and summary

•   Clinical Evaluation Preparation

 

HaMaDa brings a wealth of knowledge to help you design clinical trials compliant with ISO 14155, prepare trial submission packages, study protocols, as well as overall management of the studies. In addition, we can provide planning and implementation of a clinical quality system according to GCP. 

 

Since 2010 it is mandatory to summarize the results of all clinical trials performed on the device in a clinical evaluation report. HaMaDa can prepare such a report for you in accordance with all the requirements presented by the EU.