Advanced Skill Certificate in Post-Market Surveillance for Health Devices

Friday, 14 November 2025 07:30:03

International applicants and their qualifications are accepted

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Overview

Overview

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Post-Market Surveillance for health devices is critical. This Advanced Skill Certificate equips professionals with advanced knowledge and skills in post-market surveillance activities.


Designed for regulatory affairs professionals, quality engineers, and clinical staff, the program covers medical device regulations, risk management, and data analysis.


Learn to effectively monitor device performance, identify adverse events, and implement corrective actions. Post-market surveillance is crucial for patient safety and regulatory compliance.


Gain a competitive edge in this vital field. Enhance your expertise in post-market surveillance. Explore the certificate program today!

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Post-Market Surveillance for health devices is a crucial area, and our Advanced Skill Certificate equips you with the expertise to excel. This comprehensive program provides in-depth training in regulatory compliance, risk management, and data analysis for medical devices. Gain practical skills in vigilance systems and adverse event reporting, boosting your career prospects in regulatory affairs, quality assurance, and medical device companies. Unique features include case studies and simulations, preparing you for real-world challenges. Enhance your career and become a vital part of ensuring patient safety. Secure your future with this sought-after certification.

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

• Post-Market Surveillance (PMS) Regulations and Standards
• Medical Device Vigilance and Reporting Systems
• Risk Management and Post-Market Clinical Follow-up
• Data Analysis and Interpretation in PMS (including statistical methods)
• CAPA (Corrective and Preventive Actions) in PMS
• Post-Market Surveillance Plan Development and Implementation
• Global Regulatory Requirements for PMS
• Auditing and Inspection in PMS

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 Description
Post-Market Surveillance Specialist (Medical Devices) Oversees the post-market surveillance of medical devices, ensuring compliance and patient safety. Manages data analysis and reporting for regulatory compliance. Key skills: regulatory affairs, risk management, data analysis.
Regulatory Affairs Manager (Health Devices) Leads regulatory strategy for medical devices, ensuring compliance with UK and EU regulations. Oversees post-market surveillance activities and manages submissions. Key skills: regulatory affairs, compliance, post-market surveillance, medical device regulations.
Clinical Data Manager (Post-Market Surveillance) Manages and analyzes clinical data from post-market surveillance activities. Ensures data integrity and supports regulatory reporting. Key skills: clinical data management, data analysis, post-market surveillance, medical device reporting.
Biostatistician (Health Technology Surveillance) Applies statistical methods to analyze post-market surveillance data, identifying trends and risks associated with medical devices. Key skills: biostatistics, data analysis, risk assessment, post-market surveillance.

Key facts about Advanced Skill Certificate in Post-Market Surveillance for Health Devices

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An Advanced Skill Certificate in Post-Market Surveillance for Health Devices equips professionals with the crucial knowledge and skills needed to effectively monitor medical devices after they enter the market. This ensures patient safety and regulatory compliance.


Learning outcomes typically include mastering post-market surveillance methodologies, understanding relevant regulations (like MDR and IVDR), and developing proficiency in data analysis and risk management techniques crucial for medical device vigilance. Participants gain practical experience in implementing and improving post-market surveillance systems.


The duration of these programs varies, but generally ranges from a few weeks to several months depending on the intensity and depth of the curriculum. Some programs offer flexible online learning options while others may be delivered through intensive classroom sessions.


This certificate holds significant industry relevance. In today's highly regulated healthcare environment, competent professionals with expertise in post-market surveillance of medical devices are in high demand. The skills acquired are directly applicable to roles within regulatory affairs, quality assurance, and clinical affairs within medical device companies and regulatory bodies. This ensures career advancement and increased employability within the medical device industry.


Obtaining an Advanced Skill Certificate in Post-Market Surveillance for Health Devices demonstrates a commitment to best practices in patient safety and regulatory compliance, making graduates highly competitive candidates. The program integrates practical exercises and case studies using real-world examples of medical device post-market surveillance.


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Why this course?

An Advanced Skill Certificate in Post-Market Surveillance for Health Devices is increasingly significant in the UK's evolving healthcare landscape. The UK's medical device market is substantial, with a considerable number of devices requiring rigorous post-market surveillance. The need for skilled professionals proficient in this area is growing rapidly, reflecting current trends in regulatory compliance and patient safety. According to recent MHRA reports, a notable percentage of reported incidents stem from inadequate post-market surveillance. This highlights the crucial role of professionals certified in such procedures. Achieving this certification demonstrates a commitment to best practices and helps professionals advance their careers in a competitive field. Post-Market Surveillance competence ensures devices remain safe and effective, directly impacting public health.

Year Number of Professionals
2022 500
2023 (Projected) 750

Who should enrol in Advanced Skill Certificate in Post-Market Surveillance for Health Devices?

Ideal Candidate Profile Key Skills & Experience
Regulatory Affairs Professionals seeking to enhance their expertise in post-market surveillance (PMS) for medical devices. Experience in medical device quality management systems (QMS) is highly beneficial. Familiarity with relevant UK regulations (e.g., MDR) is a plus.
Quality Assurance professionals responsible for health device vigilance and reporting. (The UK's MHRA receives thousands of reports annually, highlighting the importance of robust PMS.) Proven ability to analyze data, identify trends, and prepare comprehensive reports. Experience with risk management and CAPA processes is valuable.
Clinical Engineers involved in post-market device evaluation and feedback collection. Strong understanding of device functionality and clinical applications. Proficiency in data analysis and reporting tools.