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Biological Evaluation Reports and ISO 10993-1 Consulting for Medical Devices

Medical devices that come into contact with the body of a patient or user may be subject to biological evaluation and biocompatibility testing. This can include tests for cytotoxicity, genotoxicity, sensitization, intracutaneous reactivity, and more. Our team can help ensure you meet all FDA, EU, and ISO 10993-1 requirements related to biological evaluation.



We can address these common questions:

  • Does our device require biological risk assessment?
  • What are the requirements of ISO 10993-1?
  • Do we really need a biological evaluation plan?
  • What types of tests do weneed to complete?

Step 1: Outlining a Strategy in Your Biological Evaluation Plan

Most medical device manufacturers have had various testing done on their device components during the development process. In most cases, the question is whether previously completed risk assessment testing is adequate to meet ISO 10993-1 requirements. That question cannot be adequately answered without first evaluating the factors below:

  • Composition of materials
  • Manufacturing process
  • Clinical history
  • Duration of contact
  • How the device will be used

These factors all play into your biological evaluation plan (BEP) – a detailed guide outlining which testing will need to be completed in order to satisfy regulatory requirements.

Step 2: Plugging the Holes in Your Testing

Over time, you may already have completed some of the testing needed to meet the requirements of your plan and ISO 10993-1. However, it's essential that no tests are missed, especially if you are preparing to submit for regulatory approval. Our biocompatibility consultants will assess what you have now, review your standard operating procedures and validation protocols, and outline a clear path forward for getting the necessary testing completed. This will allow you to proceed to the next stage of writing a biological evaluation report (BER), which will become part of your technical documentation.

Step 3: Writing the Biological Evaluation Report

Writing a medical device BER is serious business. ISO 10993-1 mandates that biological evaluations be carried out by “knowledgeable and experienced professionals.” Our biological risk assessment team has deep knowledge of FDA and EU data requirements for medical devices and will assist in making sure you are meeting those mandates in the most efficient manner possible. Because we do not provide testing services, we have no incentive to recommend unnecessary testing.

Our involvement in BER can range from providing biological evaluation report templates that your team can use to turnkey support that can include ongoing BER maintenance.

We’re Ready to Help

Whatever your needs, Oriel STAT A MATRIX is ready to assist. Give us a call or submit an inquiry online and tell us about your specific situation.

Oriel STAT A MATRIX’s Goal

Help our life science customers meet regulatory requirements, boost efficiency, and improve patient outcomes

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