Clinical Evaluation for Medical Devices

Support at every step; from scoping and literature review to submission-ready CERs

Clinical Evaluation Document Suite in development by SciMed Consultancy – expert preparation of Clinical Evaluation Plans, Reports, and State-of-the-Art (SOTA) reviews for medical device EU MDR compliance.

Clinical Evaluation Documentation Suite

Our Clinical Evaluation Document Suite delivers integrated EU MDR compliance with a comprehensive State-of-the-Art report (SotA), Clinical Evaluation Plan (CEP), and Clinical Evaluation Report (CER).

Tailored to your device's risk classification and clinical context, this end-to-end solution ensures consistent, compliant documentation with Annex XIV, MDCG & other international guidance, and streamlines Notified Body interactions.

Clinical Evidence Gap Analysis & Remediation Planning

We assess existing documentation against MDR Annexes to identify gaps in clinical evidence and provide actionable remediation strategies, helping you avoid Notified Body nonconformities.

Regulatory expert from SciMed Consultancy conducting Clinical Evidence Gap Analysis and Remediation Planning for medical devices – identifying deficiencies and aligning with EU MDR clinical data requirements.
Developing Clinical Evaluation Strategy for medical devices – SciMed Consultancy’s structured approach to aligning device description, State of the Art, and clinical benefit with EU MDR and UK MDR expectations.

Clinical Evaluation Strategy Development

We develop regulatory strategies for clinical evaluation (MDR) that align with Annex XIV and MDCG guidance, ensuring your evidence generation roadmap meets Notified Body expectations and supports your technical documentation.

SciMed Consultancy materials for Clinical Investigation Support – preparing regulatory documentation, Clinical Evaluation Plans, and data strategies to support medical device clinical studies under EU MDR and UK MDR.

Clinical Investigation Support

We provide regulatory and operational guidance for clinical investigations (MDR), including protocol development, submission support, and oversight through Ethics Committee and Competent Authority approval.

State-of-the-Art Reports

We deliver defensible state of the art (SotA) reports that position your device within the clinical landscape, supporting benefit-risk justification and performance claims.

Clinical Evaluation Plan Authoring

We prepare structured, regulator-ready CEP documents to demonstrate proactive planning and compliance with EU regulatory requirements, supporting a smooth CE marking process.

Systematic Literature Review and Appraisal

Our rigorous systematic literature reviews (SLRs) meet the methodological standards for inclusion in your CER, enhancing the quality and traceability of your clinical evidence.

Clinical Evaluation Report Authoring

Our expert-led writing of CERs meet the stringent requirements of MDR, combining literature data, real-world evidence, and robust benefit-risk analysis for regulatory submission.