Medical Devices
ISO 13485:2016 Medical Devices Quality Management System
Deliver safe, effective medical devices that meet regulatory expectations.
About the standard
Specifies requirements for a quality management system used by organizations involved in one or more stages of a medical device life cycle, including design, production, installation and servicing. It places particular weight on meeting regulatory obligations, controlling risk, and validating processes so devices are consistently safe and effective for their intended use. It can be applied by manufacturers as well as suppliers and other parties providing related services.
Objectives of the standard
- Ensure medical devices are consistently designed, produced and delivered safely
- Support compliance with regulatory requirements across different jurisdictions
- Embed risk management throughout the medical device life cycle
- Validate and control processes critical to device safety and performance
- Provide a QMS framework usable by manufacturers and their suppliers alike
Who benefits: Manufacturers and suppliers involved in the medical device lifecycle.
Learn more about ISO 13485:2016 on the ISO website ↗Source: iso.org
Standard overview
A short overview of ISO 13485:2016 is available on the ISO website, where you can also read the full standard.
Watch overview & read the standard on iso.org ↗Learning paths
Available learning paths
Select the path that matches your role to see the full outline and continue to registration.
Foundation
2 days · 16 hours
Introductory, awareness-level training that explains the purpose, structure, key clauses, terminology, principles and business value of the standard. Suitable for beginners, employees, managers, process owners and anyone who needs a general understanding.
View details →Internal Auditor
3 days · 24 hours
For participants who conduct internal audits within their own organisation or as part of an internal audit team. Covers audit principles, planning, evidence collection, findings, nonconformities, corrective action and reporting, referencing ISO 19011.
View details →Lead Implementer
5 days · 40 hours
For participants who plan, establish, implement, maintain and improve a management system based on the standard. Covers gap analysis, scope, governance, risk-based planning, documentation, controls, performance evaluation, internal audit, management review and continual improvement.
View details →Lead Auditor
5 days · 40 hours
For participants who plan, lead, conduct, report and follow up audits against the standard. Covers audit programme management, planning, team leadership, interview techniques, evidence evaluation, nonconformity grading, reporting and follow-up.
View details →Delivery tracks
Choose how you learn
The delivery track is selected during registration, after you pick a learning path.
Online
Remote live or self-paced learning, depending on the course setup. Flexible access for professionals who prefer to learn from anywhere.
Offline
Classroom, onsite or in-house delivery. Ideal for groups and organisations that need face-to-face interaction and hands-on workshops.
Fast Track
Receive the course materials, study independently and complete the assessment within 14 days. Recommended for experienced professionals.
Certificate & assessment
What you receive
Certificate issued
AXIOS Academy Certificate of Completion
Assessment
Course assessment / exam as defined for the selected level
Verification
Every certificate has a permanent public record on the Academy register
AXIOS Academy provides training and issues its own Certificate of Completion. It operates separately from AXIOS certification: attending a course has no bearing on any certification decision, and ISO itself does not certify organisations or individuals.
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