Biological Safety

From compilation of your biological evaluation plan to preparation of the evaluation report - we support you.

knoell Biological Safety

Strategies for assessing Biological Safety of your Medical Devices

The product range of medical devices is very broad. From wound dressings, via dental materials, respiratory
devices to long term implants - whatever device you have, we will support you to get it safely on the market.

 Biological Safety Handout

Explore how knoell can support you with your Biological Safety tasks

Compilation of a biological evaluation plan Material characterisation, data gap analysis, strategy development, testing recommendations

Study concept management and study monitoring Testing for extractables/leachables, biological testing

Compilation of a biological evaluation report Toxicological risk assessment of extractable/leachable substances, conclusion on the biological safety

Zoonosis risk assessment for materials of animal origin Manufacturing process investigation, literature search for relevant pathogens, conclusion on zoonosis risk

Do not hesitate to contact our experts with outstanding expertise 

Our  experts support you in gaining access to global key markets like Europe, North & South America and Asia.

Together with our clients we build a sound market access strategy by identifying the most efficient route to place your products on the desired market.


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Medical Devices
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