Clinical Evaluation for Emergency Use Device

Authoring Clinical Evaluation Plan (CEP) and Clinical Evaluation Report (CER).

Developing Biological Evaluation Plan (BEP) and Biological Evaluation Report (BER) in line with ISO 10993.

Preparing Post-Market Surveillance (PMS) Plan and Post-Market Clinical Follow-up Plan (PMCFP).

Applying a risk-based approach, leveraging surrogate data, real-world evidence, and scientific literature.

Ensuring alignment with EU MDR Annex XIV and applicable biological evaluation standards.

Utilizing the CAPTIS® platform to streamline literature review, documentation, and collaboration.

Achieved successful CE marking under EU MDR.

Secured regulatory approval despite limited clinical data through structured evidence development.

Improved audit readiness and accelerated submission timelines with high-quality documentation.

MDR clinical evaluation support for a high-risk emergency-use device

CEP, CER, BEP, BER, PMS, and PMCF documentation

Risk-based approach using surrogate data and real-world evidence

Alignment with EU MDR Annex XIV and ISO 10993

CE marking achieved with limited clinical data