At Medicologic we take great pride in providing top-class consultants to the medical industry. We are partnering up with some of the most skilled consultants in the industry – setting the level of standards and deliveries as high as possible.

Make sure your company’s on-going processes and development-initiatives are kept up-to-date continuously. With a Service Agreement you have full flexibility. With a fixed weekly, monthly, or annually hour-budget, you have complete control over costs and consultants.

Toxicology is the key to determine whether or not a product is “safe”. The test-process consists of: 1) biological evaluation plan, 2) biological risk assessment, and 3) biological evaluation report.
Both the engineered efficiency functions, and the biological composures has to be in line with the ISO10993-guidelines applied by the FDA (USA) and EMEA (Europe) – if the product is to be introduced to various international markets.

A Clinical Evaluation Report is the written description of the clinical evaluation process.  The report contains the analysis of all inputs from e.g. risk management.
To ensure the safety of the end-user, the report can be required for all medical device classes.
The purpose of the report is to determine if there is enough clinical evidence to confirm the safety and performance of the medical device.