Clinical & Biological Evaluation: Advanced Therapies

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Summary: Specialized support for developing compliant Clinical Evaluation Plans/Reports (CEP/CER - aligned with EU MDR/IVDR and global requirements) and Biological Evaluation Plans/Reports (BEP/BER - per ISO 10993 series) including for products used in rare disease diagnosis, monitoring, or treatment. Addressing challenges like potentially limited clinical data, comprehensive literature reviews, specific risk assessments, tailored biocompatibility strategies for vulnerable populations, and thorough material characterization.

Ensuring Safety and Performance for Technologies Supporting Rare Disease Patients

Demonstrating the clinical safety, performance, and biological safety of medical technologies is critical, particularly when these innovations are intended for rare disease patients who may have unique clinical needs or vulnerabilities. Regal Intel provides dedicated expert support in developing robust Clinical Evaluation Reports (CERs) and Biological Evaluation Reports (BERs). Our goal is to ensure your technology meets stringent global regulatory requirements, such as the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), while thoroughly addressing the specific context of its rare disease application, ultimately facilitating patient access.

We provide expert guidance in developing comprehensive Clinical Evaluation Plans (CEPs) and Reports (CERs) tailored to the challenges of rare disease technologies:

• Strategic Clinical Evaluation Planning (CEP): Developing robust CEPs outlining the strategy for generating and evaluating clinical evidence, considering potential data limitations inherent in rare disease populations.
• Systematic Literature Reviews & Clinical Data Analysis: Conducting thorough literature searches and critically appraising published data; analyzing available clinical data (pre-market, post-market, real-world evidence where appropriate) to support safety and performance claims within the specific rare disease indication.
• Risk Assessment Integration: Ensuring the clinical evaluation adequately addresses risks associated with the device's use in the intended rare disease population and clinical context.
• Regulatory Compliance (EU MDR/IVDR & Global): Ensuring your CER documentation rigorously adheres to current regulatory requirements and guidance (e.g., EU MDR Annex XIV, relevant MDCG guidance).
• Notified Body & Regulatory Agency Support: Assisting with preparing documentation packages and responding to inquiries from Notified Bodies or regulatory agencies regarding clinical evidence.

Our objective is to help you build a strong, compliant body of clinical evidence appropriate for demonstrating the safety and performance of your technology within its specific rare disease application.

Biocompatibility is crucial for patient safety, especially for devices used in potentially vulnerable rare disease populations or for long-term/implantable applications common in chronic rare conditions. Regal Intel provides expert guidance aligned with ISO 10993-1 and global requirements:

• Biological Evaluation Planning (BEP): Developing risk-based BEPs tailored to the specific device, its materials, manufacturing processes, and its intended use within the rare disease context (considering patient population, contact nature/duration).
• Material Characterization Strategy: Defining necessary chemical and physical material characterization to inform the biological risk assessment.
• Biocompatibility Testing Strategy: Developing efficient, scientifically sound testing strategies based on the risk assessment, leveraging existing data where possible and recommending appropriate testing per ISO 10993 series standards.
• Biological Risk Assessment: Evaluating potential biological risks (e.g., toxicity, sensitization, irritation, systemic effects) considering the specific rare disease patient population and developing mitigation strategies.
• Compliance & Reporting (BER): Ensuring your Biological Evaluation Report (BER) comprehensively documents the evaluation, rationale, data interpretation, and conclusions, meeting ISO 10993-1 and global regulatory expectations.
• Expert Interpretation: Providing expert analysis and interpretation of material characterization and biocompatibility testing results within the overall biological safety evaluation.

Our team ensures your technology meets the stringent biocompatibility requirements for global market access, safeguarding patient health within the specific context of its advanced therapy application.