Advanced Skill Certificate in Clinical Evaluation of Health Devices

Thursday, 13 November 2025 13:19:37

International applicants and their qualifications are accepted

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Overview

Overview

Clinical Evaluation of Health Devices: This Advanced Skill Certificate equips healthcare professionals with the advanced knowledge and skills needed for rigorous device evaluation.


Learn to critically assess premarket and postmarket data, including clinical trial design and statistical analysis, for medical devices.


The Clinical Evaluation of Health Devices certificate is ideal for regulatory affairs specialists, clinicians, and biomedical engineers seeking to enhance their expertise in medical device assessment.


Master risk management and regulatory compliance best practices within the framework of the Clinical Evaluation of Health Devices process.


Advance your career. Gain a competitive edge. Enroll in the Clinical Evaluation of Health Devices certificate today!

Clinical Evaluation of Health Devices: Elevate your healthcare career with our Advanced Skill Certificate. This intensive program provides hands-on training in regulatory pathways and clinical trial design for medical devices. Gain in-depth knowledge of risk management and data analysis, crucial for navigating the complexities of device evaluation. Upon completion, you'll be highly sought-after by regulatory agencies, manufacturers, and clinical research organizations. Boost your career prospects and become a leader in medical device assessment with this unique, industry-focused certificate in Clinical Evaluation of Health Devices.

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

• Clinical Trial Design and Methodology for Health Devices
• Regulatory Affairs and Compliance for Medical Devices
• Statistical Analysis and Interpretation in Clinical Evaluation
• Risk Management and Safety Reporting for Health Devices
• Clinical Evaluation Report Writing and Submission
• Post-Market Surveillance and Vigilance for Medical Devices
• Ethical Considerations in Clinical Device Evaluation
• Health Technology Assessment and Reimbursement

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 (Medical Devices) Applies clinical expertise to evaluate the safety and efficacy of new medical devices. High demand for regulatory expertise.
Regulatory Affairs Specialist (Health Tech) Ensures compliance with regulatory requirements for medical devices throughout the product lifecycle. Strong knowledge of clinical evaluation essential.
Clinical Research Associate (Medical Devices) Supports clinical trials and evaluations, contributing to the assessment of medical device performance. Involves direct patient interaction.
Quality Assurance Specialist (Medical Devices) Oversees quality systems and processes related to the clinical evaluation and regulatory compliance of medical devices. Critical for safety and efficacy.

Key facts about Advanced Skill Certificate in Clinical Evaluation of Health Devices

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The Advanced Skill Certificate in Clinical Evaluation of Health Devices equips participants with the advanced knowledge and practical skills necessary for effective evaluation of medical devices within a clinical setting. This intensive program focuses on developing expertise in regulatory requirements, statistical analysis, and risk management related to medical device clinical trials.


Learning outcomes include mastering the design and execution of clinical studies, interpreting clinical data, and compiling comprehensive reports that meet regulatory standards. Participants will gain proficiency in utilizing various statistical methods relevant to medical device clinical trials, including survival analysis and sample size calculation.


The duration of the Advanced Skill Certificate in Clinical Evaluation of Health Devices program typically ranges from several weeks to several months, depending on the specific curriculum and delivery method. This may include online modules, workshops, and hands-on sessions.


This certificate holds significant industry relevance, catering to professionals in regulatory affairs, clinical research, biostatistics, and quality assurance within the medical device industry. Graduates are well-prepared for roles requiring expertise in the clinical evaluation and regulatory pathway of health devices. The program's focus on good clinical practice (GCP) and International Organization for Standardization (ISO) standards ensures alignment with industry best practices.


Furthermore, the Advanced Skill Certificate in Clinical Evaluation of Health Devices boosts career prospects by enhancing professional credibility and demonstrating a commitment to high-quality clinical research practices within the healthcare technology sector. The skills gained are highly transferable across various medical device sub-sectors.

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Why this course?

An Advanced Skill Certificate in Clinical Evaluation of Health Devices is increasingly significant in today's UK healthcare market. The UK's burgeoning MedTech sector, coupled with stricter regulatory frameworks like the MDR, demands highly skilled professionals. According to the UK's Department of Health and Social Care (DHSC), the number of medical device approvals has risen by 15% year-on-year for the last three years. This growth underscores the urgent need for individuals proficient in clinical evaluation, a cornerstone of product safety and regulatory compliance.

Year Approvals (Illustrative)
2020 1000
2021 1150
2022 1322

This certificate equips professionals with the advanced skills needed to navigate these complex regulatory landscapes and contribute to the safe and effective introduction of innovative medical technologies. The growing demand for expertise in clinical evaluation ensures that those holding this certificate are highly sought after.

Who should enrol in Advanced Skill Certificate in Clinical Evaluation of Health Devices?

Ideal Candidate Profile Key Skills & Experience
Awarded an Advanced Skill Certificate in Clinical Evaluation of Health Devices, this intensive program is perfect for healthcare professionals seeking to enhance their expertise in medical device regulation and clinical trial design. Existing clinical research experience is beneficial. Prior knowledge of medical device regulations (such as those from the MHRA) would be advantageous but isn't strictly required. Familiarity with data analysis and reporting is a plus.
Targeting professionals in the UK's thriving healthcare sector – approximately 1.5 million individuals work within the NHS alone. Strong analytical skills are crucial for evaluating the effectiveness and safety of new health devices. Excellent communication and collaboration skills are essential for teamwork in clinical trials and regulatory submissions.
The course is designed for those aiming for leadership roles in clinical research within the NHS, pharmaceutical companies, or medical device companies. Experience in writing clinical evaluation reports and understanding relevant guidelines (e.g., ISO 14155) will boost your chances of career advancement in this field.