Certificate Programme in Clinical Evaluation of Health Devices

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International applicants and their qualifications are accepted

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Overview

Overview

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Clinical Evaluation of Health Devices is a certificate program designed for healthcare professionals. It provides practical skills in evaluating medical devices.


This intensive program covers regulatory requirements and clinical trial design. Learn about data analysis and risk management. Participants gain valuable expertise in post-market surveillance.


The Clinical Evaluation of Health Devices certificate enhances your career prospects. It's ideal for clinicians, researchers, and regulatory affairs professionals.


Advance your career. Explore the Clinical Evaluation of Health Devices program today!

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Clinical Evaluation of Health Devices: This certificate programme provides in-depth training in the regulatory and practical aspects of evaluating medical devices. Gain essential skills in risk management, clinical trial design, and data analysis, crucial for regulatory submissions. Develop expertise in ISO 14155 guidelines and good clinical practice (GCP). Boost your career prospects in regulatory affairs, clinical research, and quality assurance within the medical device industry. This unique programme features expert-led workshops and hands-on case studies, ensuring practical application of learned knowledge. Become a highly sought-after professional in clinical evaluation.

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 of Health Devices
• Regulatory Requirements for Clinical Evaluation (including ISO 14155)
• Clinical Evaluation Plan Development & Execution
• Data Management and Statistical Analysis in Clinical Trials
• Risk Management in Clinical Evaluation
• Post-Market Surveillance and Vigilance
• Clinical Trial Design and Methodology
• Ethical Considerations in Clinical Evaluation of Health Devices
• Reporting and Documentation of 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

40% Cheaper

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 of Health Devices) Description
Clinical Engineer Applies engineering principles to healthcare technology, crucial for device evaluation and implementation. High demand for clinical evaluation expertise.
Regulatory Affairs Specialist Navigates the complex regulatory landscape, ensuring compliance for medical devices undergoing clinical evaluation. Strong regulatory knowledge is key.
Clinical Research Associate (CRA) Plays a vital role in conducting clinical trials for medical devices. Extensive experience in clinical evaluation methodologies.
Biostatistician Analyzes clinical trial data; essential for interpreting results from device clinical evaluations. Data analysis skills are vital.

Key facts about Certificate Programme in Clinical Evaluation of Health Devices

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The Certificate Programme in Clinical Evaluation of Health Devices equips participants with the essential skills and knowledge necessary for conducting rigorous clinical evaluations of medical devices. This program is highly relevant to the medical device industry, offering practical, hands-on experience.


Learning outcomes include a comprehensive understanding of regulatory requirements (such as ISO 14155 and MDR), methodologies for designing and conducting clinical studies, data analysis techniques, and report writing for regulatory submissions. Participants will gain proficiency in risk management and statistical analysis relevant to medical device clinical trials.


The program's duration is typically structured to accommodate working professionals, often spanning several months with a flexible schedule designed for online or blended learning. The specific duration may vary depending on the institution offering the Certificate Programme in Clinical Evaluation of Health Devices.


Graduates of this certificate program are highly sought after by medical device manufacturers, regulatory agencies, and clinical research organizations. The skills acquired are directly applicable to roles in clinical affairs, regulatory affairs, and quality assurance, making this a valuable investment for career advancement in the medical technology sector. This specialized training ensures competence in post-market surveillance and clinical data interpretation.


The Certificate Programme in Clinical Evaluation of Health Devices provides a strong foundation for those seeking to contribute to the development and improvement of safe and effective medical devices. It enhances employability and expertise in a rapidly growing and crucial sector.

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Why this course?

A Certificate Programme in Clinical Evaluation of Health Devices is increasingly significant in today's UK healthcare market. The rising demand for innovative medical technologies, coupled with stricter regulatory requirements, necessitates professionals with expertise in this area. The UK's National Health Service (NHS) is constantly seeking to improve patient care through the adoption of new devices, creating a strong need for rigorous clinical evaluation. According to a recent study (hypothetical data for illustration), the number of medical devices registered in the UK increased by 15% in the last year. This growth emphasizes the urgent need for skilled professionals capable of conducting thorough evaluations ensuring safety and efficacy. This certificate programme addresses these crucial industry trends by equipping participants with the skills to navigate complex regulatory landscapes and contribute to responsible innovation.

Year Registered Devices
2022 1000
2023 1150

Who should enrol in Certificate Programme in Clinical Evaluation of Health Devices?

Ideal Audience for Certificate Programme in Clinical Evaluation of Health Devices
This Certificate Programme in Clinical Evaluation of Health Devices is perfect for healthcare professionals seeking to advance their expertise in medical device regulatory affairs and clinical trial design. In the UK, the medical device industry employs over 70,000 people, with significant growth projected. This program is designed for professionals already involved in device assessment, such as clinical researchers, regulatory affairs specialists, and medical device manufacturers looking to enhance their understanding of pre-market clinical evaluation and post-market surveillance. It's also ideal for those aiming to transition into the rapidly expanding field of medical technology, requiring a strong understanding of regulatory compliance and risk management for medical devices. Experienced clinicians and medical device engineers will find it highly valuable for strengthening their knowledge base around clinical data analysis and interpretation.