Quality Assurance and Regulatory Affairs

Preclinical & Clinical Evaluation of Medical Devices

Establishing Device Safety and Effectiveness Through Real-World Evidence

Syrma Johari MedTech is the most trusted partner for the preclinical and clinical evaluation of medical devices across all risk classes. Our approach focuses on developing robust, regulation-driven strategies that ensure compliance along with market readiness.

Our team develops detailed Clinical Evaluation Plans (CEPs) tailored to device specifications, therapy areas, and risk classification. Each plan is supported by systematic literature reviews and robust clinical strategies that demonstrate device safety and performance in line with regulatory requirements.

Our Clinical Evaluation Expertise

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Clinical evaluation gap analysis

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Performance Evaluation Reports (PER) and PMPF

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Safety and Clinical Performance (SSCP) summary

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Development of Clinical Evaluation Plans (CEP) and Clinical Evaluation Reports (CER) in compliance with MEDDEV 2.7/1 Rev. 4 guidelines

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Development of Literature Search Plans and Literature Search Reports for clinical evaluation and regulatory submissions

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Post-Market Clinical Follow-Up (PMCF) planning and execution

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Clinical data Management & Clinical Study Report

Strengthen your clinical evidence strategy for faster approvals.

Talk to our team to learn how