When this applies
Every biological evaluation ends in a report. ISO 10993-1:2025 expects the conclusion for each endpoint to be documented with its evidence, and FDA and notified-body reviewers read the BER rather than the individual laboratory reports. It applies when the testing and literature work defined in a biological evaluation plan is complete, and when an existing evaluation needs to be re-concluded after a change or a new revision of the standard.
When to commission it
As soon as the last test report is in hand — the laboratory reports are inputs, not the submission. Allow two weeks from receipt of all inputs. If the plan was written by someone else, send it with the inputs; the report is structured endpoint by endpoint against the plan.
What you receive
A BER in Groenakker’s template or yours covering: a summary of every test performed with its result and GLP status; a critical analysis of each result against the endpoint and acceptance criteria; integration of literature, supplier data and existing test data where the plan relied on them; investigation of any anomalous or failed result; and a clear biological safety conclusion for the device with its residual risks, traceable to the ISO 14971 risk management file. Written to be submitted as-is.
What it does not cover
The base price covers review, analysis and documentation of the results defined in the approved plan. Regulatory meetings, consultations, responses to reviewer questions and investigations into test anomalies or failures beyond the report itself are billed separately at the hourly rate. It does not replace the plan: a report without a plan behind it is what reviewers push back on. Urgent requests — delivery in fewer than three business days from receipt — are billed at the standard hourly rate in addition to the base price, and work outside standard business hours (Monday to Friday, 8:00 AM to 5:00 PM ET, excluding observed holidays) at two times the hourly rate; both are subject to availability and confirmed in writing before work starts.
Method
A Biological Evaluation Report closes the evaluation: it gathers every test result, literature justification and existing dataset against the endpoints in the plan and states the biological safety conclusion for the device. Groenakker’s biological safety specialists take the approved plan, every laboratory report, the literature file and any supplementary data; check each result against its acceptance criteria and the endpoint it addresses; weigh the evidence across endpoints; and write the conclusion. The report is authored, reviewed and approved by qualified specialists in accordance with ISO 10993-1:2025.
Who does the work
In-house at Groenakker. The work is authored, reviewed and approved by Groenakker’s biological safety specialists under its ISO 13485:2016 certified quality system, and issued in Groenakker’s template or in your document template on request at no extra cost.
Usually ordered alongside
The Biological Evaluation Plan (GRK-1001) it reports against, a change impact assessment (GRK-1005) when the device changes afterwards, and the toxicological risk assessment (GRK-2001) where chemistry carries any of the endpoints.
