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Regulatory Consulting: Biological Evaluation

Consulting
Pricing/Discount Options: Call #2 Call #1
Unique Identifier: e88a389a-52b3-4bd1-ad2d-e3d7496c6d8c

Service Description

Biological evaluation is a critical process in the development of medical devices, aimed at assessing their safety and biocompatibility when interacting with biological systems. This evaluation ensures that the materials used do not cause adverse biological responses, and is guided by the ISO 10993 family of standards. To systematically address these requirements, it is essential to develop a Biological Evaluation Plan (BEP), detailing the specific tests and assessments needed based on the device’s intended use, material composition, and duration of contact with the body. The findings from this process are compiled into a Biological Evaluation Report (BER), which summarizes the results, demonstrates compliance with ISO 10993, and ensures the device’s safety and regulatory approval.

Offerings: Ethics & Regulatory Affairs Conformity & Compliance (certification, audit, corrective and preventive action, documentation, gap & risk analysis, etc.) Clinical Investigation Support (clinical studies & trials, coordination, design, feasibility, documentation, compliance, operations support) Development of conformity evaluation standards, protocols & tools
TEF-Health Use Case Domain: all
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Provider & Contact

Provider Country Portugal
Published Email medicaldevices@ipn.pt

Pricing is available to registered users. SMEs receive significant state-aid reductions (GBER) — or, depending on the call, free services during the funded project. Sign in or register to see the price for your organisation.

Operational Details

Service Inputs 1- Device description and general information. 2- Test reports (according to mandatory applicable standards) 3- Risk report
Service Outputs Biological Evaluation Report
Dependencies & Restrictions MDR
Certification Support CE Marking (MDR, IVDR)