Evaluation of Preclinical Data

Preclinical data refers to results obtained from sources other than tests on humans, e.g. laboratory comparison tests, cell cultures, animal experiments or phantom simulations. A summary of this data and the assessment of the current state of knowledge comes from different standards, e.g. ISO 14971 and ISO 10993, to identify the need for additional data and close any knowledge gaps. A comprehensive literature review of preclinical data provides a basis for waiving laboratory tests and can reveal relevant knowledge gaps.

Overall Assessment with the help of a Biological Safety Report
The overall assessment of biological safety begins with establishing a biological evaluation plan (BEP) as part of the risk management system. Accordingly, the analysis and evaluation of the available data and the closure of the knowledge gaps are carried out by product-specific preclinical tests in accordance with the ISO 10993 series. Finally, the data for the overall assessment is summarized in a biological evaluation report (BER). This contributes to the general assessment of biological safety and has strategic advantages in product development as well as in market approval. The BER is an essential part of the technical documentation that highlights the safety of your medical device. This is required by ISO 14971:2019 and is specified in terms of content by ISO 10993-1:2018.

Do you need any assistance in assessing the biological safety of your product?
We have many years of experience in ISO 14971 and the ISO 10993 series of standards and can provide you with experts with appropriate knowledge. Our specialists have a scientific background with laboratory experience, which guarantees a professional analysis and evaluation of preclinical data. Do not risk any security gaps or development obstacles for your medical device and let us advise you without obligation.

Our services in the field of biological safety evaluation include:

  • Conducting and updating biological safety assessments in accordance with ISO 10993-1:2018
  • Assessing the collected preclinical data regarding the biological safety of the medical device
  • Database research for a scientifically-sound assessment of the biological safety of the medical device
  • Creating a biological evaluation plan (BEP)
  • Performing tests in collaboration with GLP and ISO 17025:2017 certified and accredited laboratories
  • Literature research of preclinical data and preparation of the biological evaluation report (BER)
  • Training with training certificate

For further details regarding “Biological Safety Evaluation” or for a non-binding offer pleasecontact us.