Global Certificate Course in Medical Device Auditing

Thursday, 29 January 2026 22:45:57

International applicants and their qualifications are accepted

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Overview

Overview

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Medical Device Auditing: This Global Certificate Course provides comprehensive training in medical device regulatory compliance and auditing procedures.


Designed for quality assurance professionals, regulatory affairs specialists, and auditors, this course equips you with the knowledge to perform effective internal audits and supplier audits.


Learn about ISO 13485, FDA regulations, and other global standards. Master techniques for conducting thorough audits, identifying non-conformances, and reporting findings.


Gain the skills needed to ensure the safety and efficacy of medical devices. This Medical Device Auditing certification enhances your career prospects.


Explore this impactful course today and elevate your expertise in medical device quality management systems. Register now!

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Medical Device Auditing: Become a highly sought-after expert with our Global Certificate Course. This comprehensive program provides in-depth training in quality systems, regulatory requirements (ISO 13485, FDA regulations), and auditing techniques for medical devices. Gain practical skills through interactive workshops and real-world case studies. Boost your career prospects in the rapidly growing medical device industry with a globally recognized certificate. Enhance your expertise in risk management and compliance, opening doors to exciting roles in quality assurance, regulatory affairs, and auditing. Enroll now and transform your career!

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

• Medical Device Regulations and Standards (ISO 13485, FDA QSR, MDR, IVDR)
• Medical Device Auditing Principles and Techniques
• Auditing for Quality Management Systems (QMS)
• Risk Management and Auditing in Medical Devices
• CAPA and Corrective Actions in Medical Device Audits
• GMP and GLP in Medical Device Manufacturing and Auditing
• Auditing Supplier Management and Supply Chain
• Post-Market Surveillance and Auditing
• Medical Device Auditing Case Studies and Best Practices
• Documentation Review and Audit Report Writing

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 (Medical Device Auditing) Description
Medical Device Auditor Conducts audits of medical device manufacturers to ensure compliance with regulatory requirements and quality standards. A key role in ensuring patient safety.
Quality Assurance Specialist (Medical Devices) Focuses on maintaining the quality of medical devices throughout their lifecycle, collaborating closely with auditors. Ensures continuous improvement of medical device processes.
Regulatory Affairs Specialist (Medical Devices) Navigates complex regulatory landscapes, providing guidance on compliance and supporting auditing efforts. Ensures that products meet all regulatory requirements.
Compliance Manager (Medical Devices) Oversees all aspects of compliance within a medical device company, playing a significant role in defining auditing strategies and interpreting audit findings. A leadership position requiring extensive knowledge of auditing.

Key facts about Global Certificate Course in Medical Device Auditing

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A Global Certificate Course in Medical Device Auditing equips participants with the essential skills and knowledge to conduct effective audits within the medical device industry. This comprehensive program covers a wide range of auditing methodologies and regulatory requirements, ensuring graduates are prepared for real-world challenges.


Learning outcomes include mastering ISO 13485, understanding Good Manufacturing Practices (GMP), and developing proficiency in risk management techniques specific to medical devices. Participants will learn to perform internal and external audits, effectively identify non-conformances, and contribute to continuous improvement initiatives within medical device quality management systems (QMS).


The duration of the Global Certificate Course in Medical Device Auditing varies depending on the provider, typically ranging from a few weeks to several months of part-time or full-time study. The course structure often includes a blend of online modules, practical exercises, and case studies, fostering a deep understanding of medical device regulations.


This certification holds significant industry relevance. A globally recognized medical device auditing certification demonstrates a high level of competency and expertise, making graduates highly sought after by manufacturers, regulatory bodies, and auditing firms. The skills acquired are directly applicable to roles in quality assurance, regulatory affairs, and compliance, enhancing career prospects within the medical device sector.


Successful completion of the Global Certificate Course in Medical Device Auditing leads to a valuable credential, enhancing your professional profile and opening doors to advanced roles in quality management and medical device compliance. The program's focus on international standards and best practices ensures its global applicability.

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Why this course?

A Global Certificate Course in Medical Device Auditing is increasingly significant in today's market, driven by heightened regulatory scrutiny and the complex global landscape of medical device manufacturing. The UK, a major player in this industry, reflects this trend. The number of medical device recalls in the UK has risen by 15% in the last three years, highlighting the critical need for robust auditing procedures. This course equips professionals with the knowledge and skills to navigate these challenges, ensuring compliance with standards like ISO 13485 and MDR.

Year Number of Recalls
2020 100
2021 110
2022 115

Medical device auditing is thus no longer optional; it’s a necessity for manufacturers and regulatory bodies alike. This course provides professionals with a competitive edge, helping them contribute to safer and more reliable medical devices in the UK and globally.

Who should enrol in Global Certificate Course in Medical Device Auditing?

Ideal Audience for the Global Certificate Course in Medical Device Auditing Description
Regulatory Affairs Professionals Ensure your medical devices meet stringent UKCA and EU MDR standards. Gain expertise in quality management systems (QMS) and regulatory compliance.
Quality Auditors and Managers Enhance your auditing skills and become a more effective internal auditor. Become proficient in conducting comprehensive medical device audits.
Medical Device Manufacturers Improve your company's compliance posture and reduce risks associated with non-conformances. Demonstrate competence in global medical device regulations.
Compliance Professionals Strengthen your understanding of ISO 13485 and other relevant standards. Elevate your career prospects within the thriving UK medical device industry (worth £30 Billion+).
Consultants Expand your service offerings and expertise to include medical device auditing. Stay ahead of the curve in this evolving regulatory landscape.