Clinical Evaluation

Clinical Evaluation

We deal with the aspects of professional Consulting for medical devices

We Are A Premium Regulatory Compliance Solutions Provider For Medical Devices/IVDs

Clinical Evaluation Plan

A clinical evaluation plan is a strategic plan that defines the clinical evaluation process required by MEDDEV 2.7/1 rev 4 and EU MDR

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Literature Search Protocol & Report

Literature Search is a key part of clinical evaluation and an alternative pathway to clinical trials in order to prove the clinical safety and performance of your device

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Clinical Evaluation Report

Clinical Evaluation Report

CER documents the clinical evidence that proves the safety and performance of the medical device clinically, biologically and technically.

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Demonstration of Equivalence

The demonstration of equivalence allows the manufacturer to use clinical data from an equivalent device in the clinical evaluation to comply with the general safety and performance requirements of the MDR.

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One-Stop Solution for Clinical writing

Our CER writers are involved in a comprehensive review of clinical data derived from clinical settings, literature, state of art for assessing appropriate device safety and performance data. The CERs shall demonstrate conformity to GSPR, Benefit-Risk profile, and PMS activities.

Clinical writing

CE Marking Consultants

We have a team 20+ talented, skilled & experienced technical consultants. Our CE marking consultants help the manufacturers to place their IVD medical devices on European Market.

Document Control

We take care extra care to maintain control over documentation and client confidentiality which creates value and helps us maintain client’s best interests.

Annual Maintenance

Our Regulatory consultancy provides customizable services to update and maintain your regulatory framework and QMS and complying with the needs of various regulations.

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