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