Is Your Biocompatibility Strategy Still Compliant?

Recent updates to the ISO 10993 family of standards continue to raise expectations regarding biological safety evaluations, risk management and clinical justification.
Many manufacturers are discovering that biocompatibility documentation prepared years ago may no longer fully satisfy current notified body expectations.

Common Challenges We See

• Outdated Biological Evaluation Plans (BEP)
• Incomplete Biological Evaluation Reports (BER)
• Missing toxicological assessments
• Insufficient chemical characterisation data
• Lack of justification for omitted testing
• Legacy devices assessed under outdated standards

Maytal Biocompatibility Gap Analysis

Our specialists perform a detailed review of your existing documentation against current ISO 10993 requirements and notified body expectations.
The assessment includes:

• Biological Evaluation Plan review
• Biological Evaluation Report review
• Risk management integration assessment
• Toxicological assessment review
• Chemical characterisation strategy review
• Identification of missing evidence and testing requirements

Deliverables

Following the assessment, you will receive:
✓ Detailed gap analysis report
✓ Risk-based prioritisation of findings
✓ Recommended remediation plan
✓ Regulatory strategy to support MDR compliance

Why Perform a Gap Analysis Now?

Notified bodies are increasingly scrutinising biological safety evidence, particularly for legacy devices and products undergoing MDR transition.
A proactive assessment can significantly reduce delays during certification reviews and technical documentation assessments.

Need an Independent Review?

Maytal's senior consultants have extensive experience supporting manufacturers, notified bodies and regulatory submissions across Europe and international markets.

Contact us to discuss your ISO 10993 biocompatibility strategy and identify potential gaps before your next audit or certification review.