Evaluation

Does your clinical evaluation still fulfil the latest requirements? Do you need a completely new evaluation, or will a gap analysis be enough?

We can assess your evaluation report on the basis of recognised regulations and provide you with recommendations on the specific action you need to take to remain fully compliant.

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Clinical Evaluation

Does your clinical evaluation still fulfil the latest requirements? Do you need a completely new evaluation, or will a gap analysis be enough?

We can assess your evaluation report on the basis of recognised regulations and provide you with recommendations on the specific action you need to take to remain fully compliant.

Usability

To make sure a medical device can be used intuitively and safely, your initial product development process has to be focused on usability.

We assess your evaluation report based on recognised rules. To give you security we provide  you with specific recommendations for action.

Proof of Medical Benefit

The medical benefits of medical devices with therapeutic effect must be evidenced according to the requirements of the German National Association of Statutory Health Insurance Funds (GKV). Evidence is generally provided via small-scale case studies, the results of which are summarised in a case report by independent medical specialists.

We can draw on over 20 years of experience in evaluating products and preparing evaluation reports and assessments to support you in this process.

Software

Software used as a medical device is subject to various documentation requirements and presents a major challenge for manufacturers.

We will work together with you to prepare the technical documentation and the software validation report, as well as to assess your cyber security measures for the European and US markets.

Biocompatibility

The first step in improving biocompatibility consists of the contact classification and the chemical characterisation assessments. These initial steps are then followed by product and application-specific testing and evaluation before the biocompatibility testing process is completed.

We can take care of the selection and evaluation steps, and recommend the tests you need to complete.

Studies

Clinical data has to be collected for all new devices, and to close any gaps in information discovered during the clinical evaluation process.

We can evaluate completed studies for you to confirm whether these are sufficient for a German Medical Technical Aids Register (HMV) application or a conformity assessment procedure.

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