About This Course
The ISO 13485 Lead Implementer programme gives you the practical skills to plan, implement, manage and continually improve a medical devices quality management system. Delivered fully self-paced and online, it follows a proven best-practice approach — from securing management buy-in and defining scope, to deploying controls, monitoring performance and preparing for certification.
ISO 13485 is the international quality management standard for organisations that design and manufacture medical devices. By the end you’ll be ready to lead a QMS implementation project and help your organisation achieve ISO 13485 certification.
Course Information
What You Will Learn
Course Curriculum
- Core concepts of Medical Devices Quality Management
- The ISO 13485 framework and requirements
- Securing management commitment
- Defining scope, policy and objectives
- Risk and opportunity assessment
- Setting objectives and operational planning
- Regulatory requirements for medical devices
- Design and development controls
- Deploying processes and controls
- Documented information and records
- Awareness, training and communication
- Risk management across the product lifecycle
- Monitoring, measurement and evaluation
- Internal audit and management review
- Nonconformity and corrective action
- Traceability, complaints and vigilance
- The competency domains
- Revision and exam technique
- Booking and sitting the PECB exam
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All You Need to Know
This programme suits professionals responsible for building or running a QMS, including managers, consultants, Medical Devices Quality Management specialists and project team members preparing an organisation for ISO 13485 certification.
A fundamental understanding of ISO 13485 is recommended. If you’re new to the standard, the Foundation-level programme is a good starting point.
The programme prepares you for the PECB Certified ISO 13485 Lead Implementer exam, which assesses the competency domains for designing, implementing and managing a QMS. Completing the training also earns 31 CPD credits.
Frequently Asked Questions
Yes — it is delivered online and self-paced, covering the same competency domains as PECB’s instructor-led programme so you can study around your schedule.
Lead Implementer prepares you to build and run a QMS; Lead Auditor prepares you to audit one against ISO 13485. Many professionals earn both.
A fundamental understanding of ISO 13485 is recommended, but the programme builds the concepts up methodically.
After passing the exam and meeting PECB’s requirements you can apply for the PECB Certified ISO 13485 Lead Implementer credential.
Yes — the self-paced kit includes one certification exam and one free exam retake.