Historically, biological safety assessments for medical devices consisted of a survey of biocompatibility tests required to meet regulatory obligations. From 2009, the emphasis on the risk management process and on the characterization of materials continues to shift the biological safety paradigm.
With the release of ISO 10993-1: 2018 the focus has been shifted also on biological characterization of materials together with a safety planning and implementation processes to manage biological safety.
Manufacturers of medical devices are asked to go beyond the simple process of identifying a series of biocompatibility tests when assessing the biological safety of a device.
This means that simply contract with a test lab to perform recommended tests is no longer accepted globally.
Maytal is able to support Medical Device manufacturer to address:
  • What are the changes to the general principles that apply to the biological evaluation of medical devices?
  • How use ISO 10993-1: 2018 to create an analysis of the biological data gaps and which further testing are necessary to be executed?
  • What are the changes to the categorization and how does this affect the biological evaluation to be compliant with ISO10993-1:2018
  • When chemical characterization tests may or may not be necessary?