ISO 18562 evaluation of a medical device in contact with the breathing gas pathway
As part of a large programme of work in evaluating the safety of a new endotracheal tube device, bibra was asked to evaluate the health risks posed by exposure to potentially hazardous substances that may be transferred to the patient via the gas stream during device use.
Biocompatibility review under ISO 18562 guidelines
The client commissioned bibra to review a biocompatibility report following feedback from US FDA.
Toxicological risk assessment of leachables from a combination product
The client was developing a ready-to-use (RTU) process for the administration of a viral-based product in a clinical setting. Bibra was requested to assist with the assessment of extractables during the development phase and leachables in the final RTU process - viral vector product.
Biocompatibility evaluation of a series of autoinjector medical devices
The company manufactures a range of parts for use as components in a variety of medical devices.
Toxicological risk assessment of leachables from a syringe medical device
The company had commissioned leachables studies on a syringe medical device intended for flushing of intravenous catheters/tubing with saline. The leachables profile was examined at two time points (day 0 and about 2 months) and numerous substances were detected at low concentrations.