Global Certificate Course in Clinical Evaluation for Medical Devices

Friday, 13 February 2026 11:12:04

International applicants and their qualifications are accepted

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Overview

Overview

Global Certificate Course in Clinical Evaluation for Medical Devices provides essential knowledge for professionals involved in medical device development and regulation.


This course covers clinical data, regulatory requirements, and post-market surveillance. It's designed for medical device professionals.


Learn to navigate the complexities of clinical evaluation and ensure compliance. Gain a global perspective on medical device regulations.


The Global Certificate Course in Clinical Evaluation for Medical Devices equips you with practical skills.


Advance your career and enhance your expertise. Explore the course details and register today!

Clinical Evaluation of medical devices is critical, and this Global Certificate Course provides comprehensive training to excel in this field. Gain in-depth knowledge of regulatory requirements (ISO 14155) and best practices in clinical data management and analysis. This online course offers flexibility and expert instruction, boosting your career prospects in regulatory affairs, clinical research, and quality assurance for medical device companies. Enhance your expertise and become a highly sought-after professional in medical device clinical evaluation with this globally recognized certificate.

Entry requirements

The program operates on an open enrollment basis, and there are no specific entry requirements. Individuals with a genuine interest in the subject matter are welcome to participate.

International applicants and their qualifications are accepted.

Step into a transformative journey at LSIB, where you'll become part of a vibrant community of students from over 157 nationalities.

At LSIB, we are a global family. When you join us, your qualifications are recognized and accepted, making you a valued member of our diverse, internationally connected community.

Course Content

• Introduction to Clinical Evaluation for Medical Devices
• Regulatory Requirements for Clinical Evaluation (e.g., ISO 14155, MDR)
• Clinical Evaluation Plan (CEP) Development and Implementation
• Post-Market Surveillance and Clinical Follow-up
• Data Collection and Management in Clinical Evaluation
• Risk Management in Clinical Evaluation
• Statistical Analysis for Clinical Data
• Writing a Clinical Evaluation Report (CER)
• Case Studies in Clinical Evaluation

Assessment

The evaluation process is conducted through the submission of assignments, and there are no written examinations involved.

Fee and Payment Plans

30 to 40% Cheaper than most Universities and Colleges

Duration & course fee

The programme is available in two duration modes:

1 month (Fast-track mode): 140
2 months (Standard mode): 90

Our course fee is up to 40% cheaper than most universities and colleges.

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Awarding body

The programme is awarded by London School of International Business. This program is not intended to replace or serve as an equivalent to obtaining a formal degree or diploma. It should be noted that this course is not accredited by a recognised awarding body or regulated by an authorised institution/ body.

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  • Start this course anytime from anywhere.
  • 1. Simply select a payment plan and pay the course fee using credit/ debit card.
  • 2. Course starts
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Got questions? Get in touch

Chat with us: Click the live chat button

+44 75 2064 7455

admissions@lsib.co.uk

+44 (0) 20 3608 0144



Career path

Career Role (Clinical Evaluation Medical Devices) Description
Clinical Evaluation Specialist Leads the clinical evaluation process, ensuring compliance with regulations. High demand for expertise in risk management and regulatory affairs.
Regulatory Affairs Manager (Medical Devices) Manages regulatory submissions and approvals, working closely with clinical evaluation teams. Strong knowledge of clinical data interpretation is crucial.
Clinical Research Associate (CRA) - Medical Devices Supports clinical trials for medical devices, focusing on data collection and analysis. Experience in GCP and relevant medical device regulations are essential.
Biostatistician (Medical Devices) Analyzes clinical trial data and provides statistical support to the clinical evaluation process. Expertise in statistical software and medical device regulations are necessary.

Key facts about Global Certificate Course in Clinical Evaluation for Medical Devices

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A Global Certificate Course in Clinical Evaluation for Medical Devices equips participants with the essential knowledge and skills to conduct robust and compliant clinical evaluations. This comprehensive program covers all aspects of the clinical evaluation process, from planning and execution to reporting and post-market surveillance.


Learning outcomes include a thorough understanding of regulatory requirements (like ISO 14155 and MDR), the development of clinical evaluation plans, the execution of clinical investigations, and the compilation of comprehensive clinical evaluation reports. Participants will gain practical experience in risk management and data interpretation relevant to medical device clinical trials.


The duration of the course varies depending on the provider, typically ranging from a few days of intensive training to several weeks of modular learning. Many courses offer flexible online learning options, accommodating diverse schedules and geographical locations. Check specific course details for precise durations and formats.


This Global Certificate Course in Clinical Evaluation for Medical Devices holds significant industry relevance. Completion demonstrates a commitment to quality and regulatory compliance, enhancing career prospects in regulatory affairs, quality assurance, and clinical research within the medical device industry. The skills gained are highly sought after by manufacturers, notified bodies, and regulatory agencies worldwide.


Successful completion of the program leads to a globally recognized certificate, showcasing expertise in clinical evaluation best practices and regulatory compliance for medical devices. This certification can significantly boost professional credibility and open doors to various career advancement opportunities.

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Why this course?

Global Certificate Course in Clinical Evaluation for Medical Devices is increasingly significant in the UK's burgeoning medical device sector. The UK boasts a thriving medical technology industry, with a growing demand for professionals proficient in clinical evaluation. This surge reflects the rising regulatory scrutiny and the need for robust evidence generation to ensure patient safety and product efficacy. A recent report suggests approximately 30% growth in medical device companies seeking clinical evaluation expertise between 2022 and 2023.

Year Number of Professionals
2022 1500
2023 2200
2024 (Projected) 3000

Gaining a Global Certificate demonstrates a commitment to best practices and enhances career prospects for those involved in medical device clinical evaluation, regulatory affairs, or quality assurance. Completion of such a course equips professionals with the knowledge and skills necessary to navigate the complex regulatory landscape and contribute significantly to the safe and effective launch of novel medical devices.

Who should enrol in Global Certificate Course in Clinical Evaluation for Medical Devices?

Ideal Audience Profile Relevance & Benefits
Regulatory Affairs Professionals seeking to enhance their expertise in medical device clinical evaluation. Gain a deep understanding of regulatory requirements (e.g., MDR, UKCA), improve clinical evaluation plan (CEP) creation, and demonstrate compliance expertise.
Clinical Research Associates (CRAs) involved in medical device trials and data analysis. Improve data interpretation, contribute effectively to post-market surveillance, and confidently navigate the complex landscape of clinical evidence generation.
Quality Assurance professionals working within medical device companies. Strengthen your quality management system (QMS) by ensuring robust clinical evaluation processes. Over 10,000 medical device companies operate in the UK, making this skillset highly valuable.
Medical Device engineers and designers. Understand the clinical evidence requirements from design to post-market surveillance, leading to improved product design and reduced risks.