Clinical evaluation: The precondition for market approval
We help you compiling a clinical evaluation that complies with European and US regulations
and helps to quickly and safely get market approval for your medical device.
What we can do for you
Within a few days, our physicians will help you compile a clinical evaluation that
- meets legal requirements (e.g. FDA, MEDDEV 2.7.1, Medical Device Directive) and helps you avoiding problems in market approval processes, audits and inspections
- and therefore avoiding delay of market release and related losses ,
- you can use to demonstrate the benefit of your product -- also an important sales argument,
- provides you with necessary input for your risk management file. This will be convincing for your auditors.
How we will help you
Option #1: "Help for self-help"
We will study your clinical evaluation and tell you exactly in two days what you have to do to achieve compliance with regulatory requirements. We will help you for example
- by answering your questions (via e-mail and phone). We even do that for free! (more information here)
- by reviewing your clinical evaluation and providing improvement suggestions (or directly implementing it)
- with templates, which we exemplarily and specifically create for your product and then you "only" need to fill in the blanks
Option #2: "We do the work for you"
Alternatively we compile the complete clinical evaluation for your medical product. This includes
- the literature research,
- the assessment of all data based on relevance, significance and
- the documentation of your clinical evaluation including search strategy, search results, assessment criteria, quantitative and qualitative results, summary and final evaluation.
With this 100% compliant clinical evaluation you have the precondition to safely pass audits and inspections and to get market approval in Europe or in the US.