Risk assessment

Applicable Standards:

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

Toxicological Risk Assessment

It balances identified risks with clinical benefit using compounds identified at known levels and other relevant biological tests. It is written in accordance with ISO 10993-17 and is typically used in conjunction with chemical characterization testing according to ISO 10993-18.

It may include:

• Leaky / removable compound examination (chemical characterization test)
• Search NOAEL / RfDs / BMD for applicable route of administration
• Calculate safety margins

Biological Risk Assessment

It balances the detected risks with clinical benefit to the patient. (This looks at the process versus biological and chemical testing to address the overall risk compared to a device's material and patient benefit.)

Available for address:

• Test errors
• Process / material / location changes
• Exclusion from testing
• Material review - literature search at specific endpoints

Biological Assessment Plan

The Biological Assessment Plan (BEP) is the first risk assessment offered by Nelson Labs and aims to meet the objectives of ISO 10993-1, clause 4 "General principles applicable to the biological assessment of medical devices". The first part of this article specifically states that "Biological assessment should be planned, implemented and documented by knowledgeable and experienced professionals". BEP takes into account the materials, processing, and historical use of the device. The output is a signed bioassessment plan that proposes the testing and information required to demonstrate device safety.

Biological Assessment Report (BER)

The Biological Assessment Report (BER) is designed to meet the requirements set out in ISO 10993-1: 2018, clause 7: “Expert assessors with the necessary knowledge and experience should identify and document:

• the strategy and planned content for the biological evaluation of the medical device;
• criteria for determining the acceptability of the material for the intended purpose; depending on the risk management plan;
• adequacy of material characterization;
• justification for selection and / or waiver of tests;
• interpretation of existing data and test results;
• Any additional data need to complete the biological assessment;
• general biological safety result for the medical device. 

Opinion Note

Provide your opinion on a specific device state. This is most appropriate when the interview does not have to be complex or broadly implemented. Usually this is a 1-2 page document signed by a consultant. This is a high level review of what is done following the recommendations on next steps (tests and / or further risk assessment).

Gap analysis

Evaluating changes in regulatory standards for which previous tests were carried out against the most recent regulatory standards.

This usually includes:

• Review of each standard defined in the request
• Review of previous tests
• Recommend tests required to comply with most existing standards

EUROLAB, with its highly expert team and internationally accredited laboratories, Risk assessment It performs all test, analysis, measurement, evaluation and report generation services completely and reliably.