Clinical & Biological Evaluation

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Summary:  Development of compliant Clinical Evaluation Plans/Reports (CEP/CER - MEDDEV 2.7/1 rev 4) and Biological Evaluation Plans/Reports (BEP/BER - ISO 10993-1), including literature reviews, data analysis, risk assessment, biocompatibility testing strategies, and material characterization.

Demonstrating the safety and performance of your medical devices is paramount for regulatory approval. Regal Intel provides expert guidance in the development of comprehensive Clinical Evaluation Plans (CEPs) and Clinical Evaluation Reports (CERs). We understand the intricacies of EU MDR and other global regulatory requirements, and our services include:

• Clinical Evaluation Planning: Developing robust CEPs that outline the strategy for demonstrating clinical safety and performance.
• Literature Reviews and Clinical Data Analysis: Conducting thorough reviews of relevant literature and analyzing clinical data to support your claims.
• Risk Assessment: Assessing and mitigating potential risks associated with your medical device.
• Compliance with MEDDEV 2.7/1 rev 4 and Other Guidance: Ensuring your CERs adhere to the latest regulatory guidelines.
• Notified Body Interactions: Assisting with communication and submissions to Notified Bodies.

Our goal is to help you build a strong foundation of clinical evidence that demonstrates the safety and performance of your medical devices, ensuring successful market access.

Biocompatibility is a critical aspect of medical device safety. Regal Intel provides expert guidance in the development of Biological Evaluation Plans (BEPs) and Biological Evaluation Reports (BERs) in accordance with ISO 10993-1 and other relevant standards. Our services include:

• Material Characterization: Assessing the materials used in your medical devices to determine their potential biological effects.
• Biocompatibility Testing Strategy Development: Developing tailored testing strategies to ensure the biological safety of your devices.
• Risk Assessment: Evaluating potential biological risks and developing mitigation strategies.
• Compliance with ISO 10993-1 and Global Regulatory Requirements: Ensuring your BERs meet the latest regulatory standards.
• Expert Interpretation of Biocompatibility Data: Providing expert analysis and interpretation of biocompatibility testing results.

Our team ensures your medical devices meet the stringent biocompatibility requirements for global market access, safeguarding patient health and ensuring regulatory compliance.