Compliance with ISO 10993 and ISO 18562
Experience With Global Regulations
As part of the regulatory compliance for medical devices, a robust and structured biological safety risk assessment, in compliance with ISO 10993 and the relevant regional medical device regulation is required.
We produce risk assessments in compliance with ISO 10993 and ISO 18562 as required by the various authorities around the world including EU-notified bodies, MHRA and US FDA.
Assessing the biological safety of devices
ISO 10993 requires that the nature and duration of contact with the device is considered to establish the appropriate biological endpoints to be considered. Chorley Consulting normally advises a staged approach to assessing the biological safety of devices:
Production of a Biological Evaluation Plan (BEP)
We will consider the intended application of the device, the materials used in the construction, the production methods and the primary packaging.
Existing data on the same or similar devices, together with available literature-sourced information on the ingredients and materials used will be used to develop a plan to assess the biological safety of the device in line with the latest ISO 10993 guidance documents. Where possible, reasoned arguments will be constructed to minimise any experimentation.
Conduct of any testing indicated in the BEP
The MDR requires medical device manufacturers to demonstrate the quality and compliance of all critical suppliers. This includes providers of biocompatibility and E&L testing.
We can manage your biocompatibility studies, audit the GLP and animal welfare standards of laboratories or monitor specific studies at your chosen laboratory.
Production of a Biological Evaluation Report (BER)
The BEP will be updated with the results of any testing required and the results considered in the context of the application of the device.
A final risk assessment and conclusion on the overall biological safety of the device will be made.