Biological Evaluation
Biological Safety Evaluation for Medical Devices
Historically, biological safety evaluations for medical devices consisted mainly of performing biocompatibility tests required to meet regulatory obligations.
Since 2009, the focus on risk management processes and material characterization has shifted the paradigm of biological safety. With ISO 10993-1:2018, emphasis has moved toward the biological characterization of materials, along with safety planning and implementation processes to manage biological safety.
Medical device manufacturers are encouraged to go beyond simply identifying a set of biocompatibility tests. Contracting a lab to perform the recommended tests is no longer sufficient to meet global regulatory expectations.
Maytal can support medical device manufacturers to:
Define an overall biological evaluation strategy for the product, starting from the earliest prototype stages, including guidance on selecting the most suitable materials
Prepare a Biological Evaluation Plan (BEP) in accordance with ISO 10993-1
Assist in selecting and evaluating testing laboratories, addressing endpoints not covered by literature data
Prepare the Biological Evaluation Report (BER), critically reviewing laboratory test results to ensure full compliance with ISO 10993-1
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