tecurat GmbH – Knowledge of the industry for the industry
We will show you how to utilize the information from prior clinical applications in the early stages of development to maximize the overall benefit for the patient.
We give you tips on how to take your medical devices in the field more into account in post-market surveillance planning, and how to score successfully in risk management.
We are ready to help you find the right study design for your clinical trial, and support you with the necessary documentation requirements in your role as a sponsor.
Are you not yet familiar with these topics in connection with clinical data or do you have other concerns in terms of clinical affairs? Then make an appointment with us.
The field of clinical affairs encompasses so much more than the consideration of the regulatory requirement of a clinical evaluation & trial.
Already with the emergence of the first product idea, you as a manufacturer should always consider your medical device from the perspective of the risk-benefit analysis of your future patient population. Thus, clinical expertise comes into play for the first time with the definition of the intended purpose. Even if the intended purpose is usually formulated unspecifically and rather vaguely, a sufficient medical understanding of the respective indication is indispensable.
The decisive factor for the approval and placing on the market of your product is the scientifi-cally valid proof of a clinical benefit with a balanced risk/benefit ratio for the patient.
Ethics and Standards
Every direct patient contact as well as scientific examination on humans must be carried out in strict compliance with the ethical & clinic-related regulations.
The massive cornerstone of any medical inter-vention. These likewise include the product-related stand-ards of quality & risk management.
Feedback & suggestions for improvement
And even after the marketentry of your medical device, the cooperation & voice of the clinical experts is relevant – for example in planned PMCF studies, or the risk assessment after safety feedback from the field, when it is neces-sary to assess and control patient impairments through risk-minimizing measures.
We are happy to be there for you
Meet up with us:
In the office or online – or send us an email whenever you want.
We look forward to meeting you!