Biological Evaluation Plan

Biological Evaluation Plan is an initial step in the Biological Evaluation of Medical Devices. Since the Biological evaluation is part of the risk management process, it shall be planned, carried out and documented by knowledgeable and experienced professionals. We have experts to prepare Biological Evaluation plan. 

Biological evaluation starts with categorizing the device and gathering information about the device, including materials, manufacturing process and historical use. The data collected shall be analyzed for the gap (Gap analysis) to facilitate the recommendation of tests and information needed to demonstrate device safety.

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Factors considered during Biological Evaluation:

• Medical device configuration (e.g., size, geometry, surface properties)

• The material(s) of construction (i.e., all direct and indirect tissue contacting materials);

• The physical and chemical characteristics of the material(s) of construction and their composition;

• Manufacturing Process

• Intended additives, process contaminants and residues during the manufacturing of the device

• Packaging materials that directly or indirectly contact the medical device

• Leachable substances 

• Degradation products

• Other components and their interaction in the final product

• The physical characteristics of the final device

• Any history of clinical use or human exposure data

• Any existing toxicology and other biological safety data on product and component materials