Quality Management
ISO 13485 — Medical Devices Quality Management System
Levels available
Course types, duration & fees
| Course type | Who should attend | What your company benefits | Duration | Fee |
|---|---|---|---|---|
| Foundation | Those who wish to learn the basis of implementing the management system and its processes | Provide the organization with best-practice based orientation and mindset culture by understanding the main important elements of ISO standards | 2 days | HKD 4,400 |
| Lead Implementer | Responsible persons for implementing and managing the management system in their company | Improve overall processes by implementing best practices led by competent staff that can lead to compliance with ISO standards | 5 days | HKD 11,200 |
| Lead Auditor | Responsible persons for auditing and monitoring management systems in their company | Ensure your management systems are implemented properly by having competent staff audit the processes that can lead to a successful compliance and certification | 5 days | HKD 11,200 |
About the standard
ISO 13485 sets the quality management requirements for the medical devices industry, covering the full device life cycle from production through post-production, decommissioning, and disposal. It is used both by manufacturers and by certification bodies supporting the certification process, giving organizations a proven framework for developing and maintaining efficient, compliant processes that deliver safe, reliable medical devices.
Levels available
- Foundation — For those who want to learn the basics of a medical devices quality management system and its processes under ISO 13485.
- Lead Implementer — For those responsible for implementing and managing a medical devices QMS in their organization.
- Lead Auditor — For those responsible for auditing and monitoring a medical devices QMS to support compliance and certification.
Who should attend
Quality and regulatory affairs professionals in the medical devices industry, along with implementers, auditors, and consultants who support manufacturers or certification bodies, should attend. It is well suited to anyone aiming to demonstrate commitment to product safety and continuous improvement in a regulated industry.
Learning objectives
- Understand the requirements of ISO 13485 across the medical device life cycle.
- Learn to implement and manage a QMS tailored to medical device manufacturing and post-market processes.
- Gain the competence to audit a medical devices QMS for conformity.
- Develop the ability to identify and address quality and safety risks specific to medical devices.
Why attend
Certification increases job opportunities and earning potential, since large medical device companies actively seek professionals who can demonstrate this expertise. It also builds new business connections and competitive advantage by proving your ability to help an organization deliver safer, more effective medical devices and increase customer trust.
PECB link
https://pecb.com/en/education-and-certification-for-individuals/iso-13485