Clinical Evaluation Report & Document Preparation

We specialize in clinical evaluation-based approvals — no new clinical trials required. From literature reviews to clinical evaluation plans and CER preparation, we deliver end-to-end support grounded in scientific evidence.

Service Overview

Many medical devices can achieve PMDA approval through clinical evaluation using existing clinical literature and data — without conducting new clinical trials. MK Consulting specializes in this approach, significantly reducing cost and time while ensuring reliable approval. We also handle the full preparation of approval applications and supporting documentation.

Clinical Evaluation Process

STEP 01

Clinical Evaluation Plan (CEP)

We develop a clinical evaluation plan defining the scope, methods, and acceptance criteria based on your product's characteristics and risk profile.

STEP 02

Literature Search & Screening

We conduct systematic literature searches across PubMed and other medical databases, followed by rigorous screening and quality appraisal.

STEP 03

Data Analysis & Evaluation

We analyze the collected clinical data to build a scientific evidence base for your device's safety and performance.

STEP 04

Clinical Evaluation Report (CER)

We prepare a CER meeting PMDA's format and quality requirements, with clear logical structure for reviewers.

STEP 05

Document Preparation & Submission

We prepare approval applications and all supporting documentation, supporting you through submission and the review process.

Why MK Consulting

Proven track record in clinical evaluation-based approvals (no new clinical trials)
Deep medical knowledge and literature appraisal expertise in GI endoscopy
Practical CER preparation aligned with PMDA review standards and guidance
End-to-end service from literature search to submission reduces cost and time
English support for overseas manufacturers

Frequently Asked Questions

Q. Can we get approval without conducting new clinical trials?

A. Yes, many devices can achieve PMDA approval through clinical evaluation using existing clinical literature and data. Applicability depends on the product — please contact us for an assessment.

Q. How long does CER preparation take?

A. Typically 3–6 months depending on product complexity and literature volume. Including document preparation, the full process takes approximately 6–12 months.