Clinical evaluation: The precondition for market approval
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.
Interested? Here are your next steps:
Call us, write us an e-mail or fill out the contact form so that
- we understand your situation
- we both can sign a confidential agreement (if required)
- we create a customized quote just for you
- we will support you with our full competency
You can reach us
- by mail: mail@johner-institut.com
- by phone in Europe (Germany): +49 (0) 7531 94500 20
- by phone in the US: (301) 244 6335
- by filling out the contact form
What makes us different
- compiled in a very short time:
We are highly specialized on clinical evaluations. Or physicians are very experienced and have done it more than 100 times. Faster help means for you no waste of time and faster sales. Therefore we are very fast what means for you no waste of time and faster sales. - at minimal cost:
Not only that we work fast, but we also will empower you to to accomplish as you like as much work yourself. This immediately will minimize your cost and make you independent on consultants i.e. you will also save money also in a long run.
- 100% ISO 14971-compliant:
Risk management files are more often rejected than any other type of documents. Our experts are also auditors at notified bodies and know exactly, what is required. They make sure that you will avoid embarrassing complaints and time consuming, costly re-certifications and re-submissions. This enables you to pass approval without stress, delays and unnecessary costs. - risk-free:
Because we have done more than one hundred software documentations, we precisely can estimate efforts and costs. This gives you an absolute safety in your planning. In addition, we also give you a 100% satisfaction guarantee. You pay nothing if you are not completely satisfied.
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