What is Biological Evaluation Report?
Following completion of the activities outlines in the Biological Evaluation Plan, a final assessment of the data is given within The Biological Evaluation Report.
The report is a collective summary of all data used to assess the biocompatibility of a medical device. The overall biological risk of the device is considered. The report will include final statements to assess if all risks have been identified and controlled and the device is biologically safe for its intended use.
It is essential that the biological evaluation report is reflected within the risk management process by providing an overall biological risk of the device. The report will include final statements to assess if all potential risks have been identified and all of the risk controls are suitable and effective.
It is important that manufacturers periodically review the biological evaluation to determine if any updates are required. Additionally, the biological evaluation should be re-evaluated if changes to any of the following occur:
- processing: sterilisation, cleaning, manufacturing procedure
- material source (new vendor)
- material specification
- formulation
- storage conditions
- environment of clinical use
All of the above changes may affect the biocompatibility of the device. It is therefore necessary to assess the risk associated with each change and determine if any additional data is required to confirm biological safety.
It is a requirement that the “Biological evaluation should planned, carried out and documented by knowledgeable and experienced professionals”. Using our in-house toxicologist, Test labs offer a biological evaluation report (BER) which will identify the tests needed for your medical device, as well as sourcing available information on your product. After constructing the BEP and performing the required tests and sourcing the biocompatibility information, Test labs offer a biological evaluation Report (BER) with the complete set of justifications and results on your product.
Explore our medical device testing services
Clinical Evaluation
We develop and implement procedures to collect, appraise, and analyse clinical data pertaining to your medical device.
Medical devices bioburden testing
Our team will determine the presence or absence of bioburden on your sterile or non- sterile medical devices.
Disinfection products for medical devices
We test the efficacy of a wide range of disinfectants for medical devices, including disinfection technologies and robots.
Explore our laboratory areas
Microbiology Laboratory
We are fully equipped to perform a wide variety of microbiology tests using bacteria, yeast, fungi, and bacterial spores.
Test chambers
We have built state of the art Test Chambers – all with a stainless steel interior and equipped with a wide range of sensors.
Chemistry Laboratory
Our chemistry lab is fully equipped to perform a wide variety of tests, that supports formulation and materials
development.
