- 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
Contact us now
What makes us different
We make sure that your clinical evaluation is
- compiled fast:
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.
- 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% compliant with European and FDA regulations:
Our experts are not only physicians themselves but also auditors and know exactly, what is required. They make sure that you will avoid embarrassing complaints and time consuming, costly re-certifications. This enables you to pass approval without stress, delays and unnecessary costs.
Because we have done more than one hundred clinical evaluations, 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.
Contact us now, so we can plan together how you can get your software documentation at a minimal cost, in a very short time!
You can reach us
Contact us now