Tailored specifically for the medical device industry, ISO 13485 defines the requirements for a comprehensive Quality Management System (QMS) that ensures the consistent design, production, and delivery of safe and effective medical devices, meeting strict regulatory demands like FDA (21 CFR Part 820) and EU MDR.
Our Exemplar Global certified courses, developed by professionals with deep industry experience, are essential for anyone in the medical device sector. From foundational training for newcomers to advanced Lead Auditor certification, we provide the critical expertise needed to navigate this complex, high-stakes regulatory environment and ensure patient safety.
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USD 695.00
Created by industry professionals and certified by Exemplar Global, this 40-hour course includes everything you need to become a Certified Lead Auditor and set up an audit program at your organization. As well as auditing techniques and audit reporting, tuition includes a solid overview of ISO 13485 and its requirements, documentation, implementation, best practices and practical tips.
40 hours (on demand)
Certificate of Completion
Exemplar Global certified
(222)
USD 495.00
This Exemplar Global-certified course teaches learners the skills needed to audit their organization's ISO 13485 Quality Management System for Medical Devices. Topics include an overview of ISO 13485 and its requirements, documentation, implementation, auditing strategies and techniques, best practices and practical tips.
16 hours (on demand)
Certificate of Completion
Exemplar Global certified
(76)
USD 495.00
Certified by Exemplar Global, this is an intensive, 24-hour course that details the ISO 13485:2016 standard, its benefits and requirements, and teaches the steps necessary to implement a Quality Management System for Medical Devices and achieve certification.
24 hours (on demand)
Certificate of Completion
(143)
USD 125.00
This course is brief (4 hours) but does a very good job of covering ISO 13485, its requirements and benefits, and explaining what a Quality Management System for Medical Devices means for your organization. A popular course that we strongly recommend.
4 hours (on demand)
Certificate of Completion
Earning your professional certification in ISO 13485:2016 is a strategic investment in the critically important medical device industry. It formally validates your expertise in Quality Management Systems for medical devices, making you an indispensable asset to employers navigating strict regulatory landscapes like FDA (21 CFR Part 820) and EU MDR.
This certification opens doors to advanced roles such as a Certified ISO 13485 Lead Auditor or a Regulatory Affairs Specialist.
StandardsCourses is an Exemplar Global Certified Training Provider (TPECS). This means our courses and examinations meet rigorous international standards. Your certificate will bear the Exemplar Global accreditation mark, ensuring it is recognized and respected by regulatory bodies and organizations worldwide.
Do I need to be employed in the medical devices sector to take one of these couses?
No, but if you're between jobs or planning to embark on a career in the sector, evidence of appropriate training would be a commendable asset. Even if the lab you're hoping to work for isn't ISO certified, high-quality ISO 13485 training is still recommended due to its coverage of risk awareness, regulatory compliance, and current best practices
How closely aligned to ISO 13485 are these courses?
The International Organization for Standardization states that ISO 13485 is "intended for any organization involved in the design, production, installation, and servicing of medical devices and related services." In these respects, our ISO 13485 training aligns very well.
Each course has been designed, written, and tested by a team of professionals with a keen understanding of both the sector and the needs of learners who in many cases are taking the course as part of their company's bid for ISO 13485 compliance.
Who is your ISO 13485 Implementer Training course intended for?
ISO 13485 Implementer Training is ideal for staff who've been assigned a key role in implementing the standard at their laboratory or organization. The course is designed to ensure that learners:
It's generally assumed that staff taking this course will have a "post implementation" role that involves helping to maintain the Quality Management System and manage its daily operation.
Could I share an ISO 13485 course?
Theoretically yes, and we're sure this happens from time to time. A pair of married learners, for example, might decide to share their login credentials and take turns at working through the training. Or perhaps the wife could complete a part of the course her husband is struggling with.
But on completion a certificate would only be issued to the learner in whose name the course is registered.
How secure is your checkout process?
The payment process is extremely secure. Transactions are processed by our payment providers, BlueSnap and PayPal, using 256-bit encryption. BlueSnap and PayPal are both certified PCI compliant, meaning their checkout systems conform to a set of protocols that secure and protect credit card data provided by cardholders when making online purchases.
In 2015, the United Nations introduced 17 Sustainable Development Goals (SDGs) as a universal call to action to end poverty, protect the planet, and ensure that by 2030 all people enjoy peace and prosperity. Becoming an expert in ISO 13485 empowers you to contribute directly to this global mission.
The skills you gain from our ISO 13485 training will allow you to help organizations make a tangible impact:
Goal 3: Good Health & Well-Being – This is the core purpose of ISO 13485. By ensuring the safety, quality, and efficacy of medical devices, you directly contribute to protecting human health and saving lives.
Goal 10: Reduced Inequalities – A robust global standard for medical devices ensures that high-quality healthcare technology can be developed and accessed more equitably around the world.
