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Risk Assessments

Applicable Standards:

  • ISO 10993-1
  • ISO 10993-17
  • ISO 14971

 

Technical documents written by Nelson Technical Consultants who are industry experts in these areas.

Toxicological Risk Assessment

Balances any identified risks with the clinical benefit to the patient using known levels of identified compounds and any other relevant biological tests. This is written in accordance to ISO 10993-17 and is typically used in conjunction with chemical characterization testing according to ISO 10993-18.

May Include:

  • Leachable/extractable compound review (chemical characterization testing)
  • Research NOAEL/RfDs/BMD for applicable route of administration
  • Calculate safety margins

Biological Risk Assessment

Balances any identified risks with the clinical benefit to the patient. (This looks at the material of a device and processing against biological and chemical tests to address overall risk compared to patient benefit.)

Can be used to address:

  • Testing failures
  • Process/material/location changes
  • Justify out of testing
  • Material review – literature research on specific endpoints

Biological Evaluation Plan

A Biological Evaluation Plan (BEP) is an initial risk assessment offered by Nelson Labs is intended to meet the objectives outline in ISO 10993-1, clause 4 “General principles applying to biological evaluation of medical devices.” The first part of this clause states specifically that “The biological evaluation shall be planned, carried out, and documented by knowledgeable and experienced professionals.” The BEP takes into consideration the materials, processing, and historical use of the device. The deliverable is a signed biological evaluation plan recommending testing and information needed to demonstrate device safety.

Biological Evaluation Report (BER)

The Biological Evaluation Report (BER) is designed to meet the requirements outlined in ISO 10993-1:2018, clause 7: “Expert assessors who have the necessary knowledge and experience shall determine and document:

  • the strategy and planned content for the biological evaluation of the medical device;
  • the criteria for determining the acceptability of the material for the intended purpose; in lie with the risk management plan;
  • the adequacy of the material characterization;
  • the rationale for selection and/or waiving of tests;
  • the interpretation of existing data and results of testing;
  • the need for any additional data to complete the biological evaluation;
  • overall biological safety conclusion for the medical device.”

Opinion Memo

Provide an opinion regarding a particular device situation. This is most appropriate when the conversation does not need to be complex or broadly applied. Typically this is a 1-2 page document with one consultant signature. This is a high level review of what has been done followed with recommendations about the next steps (testing and or further risk assessment).

Gap Analysis

Evaluation of changes in regulatory standards under which previous testing was performed compared to the most current regulatory standards.

This typically includes:

  • Review of each standard identified in the request
  • Review of testing performed previously
  • Recommend any testing needed to be in compliance with most current standards

 

Assessment Locations

 

If you have additional questions about Risk Assessments, or would like to consult with the experts at Nelson Labs, just send us a request or call us at +1 (801) 290-7500.