Literature Search of Preclinical Data

Preclinical data refers to the data, which are not resulting from tests on humans, but from e.g. laboratory comparison tests, cell cultures, animal experiments or phantom simulations. A summary of these data, as well as the current state of knowledge, are required by different standards, such as ISO 14971 and ISO 10993, to identify the need for additional data and close any knowledge gaps. A comprehensive literature search of preclinical data provides the base for the need of certain laboratory tests and reveals relevant knowledge gaps. Thus, this biological safety assessment report or BSER contributes to the overall assessment of biosafety and has strategic advantages in product development as well as in market approval. The Biosafety Report is another essential part of the technical documentation that highlights the safety of your medical device. It is required by ISO 14971 and its content is specified by ISO 10993 and can be prepared in accordance with the recommendations of ISO 15499.

NSF PROSYSTEM GmbH has extensive experience in the field of ISO 14971 and provides you experts with appropriate expertise. Our specialists have scientific backgrounds with laboratory experience, which guarantees a professional analysis and evaluation of preclinical data. Do not take any risk with security gaps or obstacles during the development of your medical device and let us advise you noncommittally.

Our services in the field of biological safety testing include:

  • Creation and update of biological safety evaluation according to ISO 10993-1 or ISO 15499
  • Evaluation of the collected preclinical data regarding the biological safety of the medical device
  • Database research for a scientifically profound assessment of the biological safety of the medical device
  • Development of a biological evaluation plan
  • Conducting tests in collaboration with GLP and ISO 17025 certified and accredited laboratories
  • Literature research of preclinical data and preparation of the corresponding report (BSER / biological safety evaluation report)

For further details regarding “Literature Search of Preclinical Data” or for a quotation just contact us.