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Avoid delays in MDR approval: How to request biocompatibility data in accordance with ISO 10993-1:2025.
Our free checklist helps manufacturers systematically analyse manufacturing processes and identify biocompatibility risks at an early stage or obtain the necessary information from suppliers in a structured manner.
The biological safety of a medical device depends on the material; however, manufacturing processes, process chemicals, contaminants and sterilisation also influence biocompatibility.
The current ISO 10993-1:2025 therefore requires a risk-based biological assessment that takes the entire manufacturing process into account.
Many manufacturers face the same challenges:
The new ISO 10993-1:2025 leaves no room for manoeuvre: anyone who does not document the entire manufacturing process completely risks the MDR conformity of their medical device. Act now!
Incomplete information on process chemicals makes your biological assessment vulnerable, leads to costly delays in the audit and causes unnecessary laboratory costs. Our checklist helps to eliminate data gaps.
Your shortcut to the BER: Use our structured query tool to obtain exactly the data on manufacturing processes, CMR substances and thermal influences that a toxicologist needs for a well-founded assessment.
Please note: If the form is not displayed, please check your browser's privacy settings. If the problem persists, do send an e-mail to [email protected].
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