The program was designed to bridge the gaps of breaking into the industry of clinical evaluation. It is infused with clinical and regulatory translational teachings on how to apply the guidance documents and regulations, navigation of new device therapies in short time periods, development of literature strategies, training on various literature software and techniques and so much more! The program aims to prepare an individual for writing clinical evaluations upon graduating, allows you to learn at your own pace and supports the areas of clinical evaluation you want to learn more about. 

At the end the program, students will be able to:

1. To describe EU MDR requirements related to clinical evaluation and post-market clinical follow-up

2. To define clinical data and it is used to support a device’s intended purpose and indications for use

3. To identify sources of clinical data across all medical device classes and develop clinical safety, performance and intended clinical benefit objectives

4. To define clinical evidence, its examples and its relationship with clinical data and clinical evaluation for all medical device classes

5. To carry out step-by-step the five stages of the clinical evaluation process according to the MEDDEV 2.7/1 Rev 4 and understand its role in the device life cycle

6. To author a clinical evaluation plan and report and its related documents such as a post-market follow-up plan and report, summary of safety and clinical performance and all the document components in its entirety in compliance with the EU MDR, MEDDEV 2.7/1 Rev 4 and applicable MDCG guidance documents

7. To conduct systematic literature searches and reviews that are reproducible

8. To appraise and analyze all clinical data sources

9. To identify when certain clinical sources are not required such as clinical investigations and/or post-market clinical follow-up is not needed

10. To understand Notified Body requirements for clinical evaluation and what to expect and how to approach an EU MDR submission

Recommended for those currently pursuing a degree in the science field and/or anyone working in regulatory, quality, risk management or clinical roles interested in creating, authoring, reviewing and editing CERs.

Participants of this program are not required to have a science background or basic knowledge of clinical evaluation reports, risk management and medical device regulation in the European Union, but it is preferred. Those with no background are strongly encouraged to engage heavily integrated teaching sessions and assignments to bridge the gaps in the scientific areas and enroll in the CLINICALExperience program.

The question is what are you looking for? This program is designed to provide you with experience in clinical evaluation that can assist in landing a job opportunity, support and career coaching every step of the way, job recommendations because we can spot roles that may best suit you, and you can complete the program all at the comfort of your home. If this fits what you are looking for, then look no further. 

The main perks of this program are internship experience that you can put on your resume and career coaching for job opportunities in the field. We will be with you until you land your first opportunity. It's as simple as that. We have all been there starting out and it's not always easy, but what better way to have someone supporting you on this journey. We also have special career coaching for international students concerning visas and navigating the work environment.

Due to the nature of our services and immediate access to the program after payment, there will be no refunds.