Medical devices quality · Implementer / lead implementer
ISO 13485 Implementer / lead implementer
How to design, build and run a management system that meets a standard — from gap analysis and scoping to documentation, risk assessment, internal audit and certification readiness. Shorter “implementation” courses take 1–2 days; lead implementer courses 3–5 days with an exam.
1 About this qualification
This is a implementer / lead implementer course applied to ISO 13485, the standard for medical devices quality.
Quality management system requirements for organisations involved in the life cycle of medical devices, written to support regulatory compliance. Unlike most standards here, it does not use the Harmonized Structure.
2 UK courses
Course names, certification, duration and delivery as stated by each provider. We do not list prices — they change often; see the provider’s page.
| Course (as named by the provider) | Provider | Certified by | Duration | Link |
|---|---|---|---|---|
| Implementing ISO 13485:2016 Training CourseLive online | BSI | Not stated | 2 days | Course pagechecked 3 October 2026 |
| ISO 13485:2016 Implementation | LRQA | Not stated | See provider | Course pagechecked 3 October 2026 |
| NQA ISO 13485 Introduction and Implementation TrainingVirtual – tutor led | NQA | Not stated | 2 days | Course pagechecked 3 October 2026 |
Certified by: Not stated (3). What the schemes mean.
3 How it is assessed
| Scheme | Typical length | Assessment |
|---|---|---|
| PECB | Lead Implementer: 5 days, exam on day 5. ISO 31000 Risk Manager: three days’ training, exam on day 4 | PECB exam; credentials from Provisional Implementer to Senior Lead Implementer depending on experience |
| IBITGQ (GRC Solutions, ISO 27001) | 3 days | CIS LI online exam, 90 minutes |
| Provider-certified (e.g. BSI) | Implementation 2 days; lead implementer 4–5 days | Lead implementer courses include an exam (BSI: its 5-day ISO 9001:2026 Lead Implementer adds two days of content with an examination to its requirements and implementation courses) |
4 How to prepare
- Lead implementer: a 3-week study planPrepare for an implementation or lead implementer course by thinking like a project manager: scope, gap analysis, risk, documentation and r…
- ISO 13485: structure and key clausesThe clauses to know before day one.
Practice questions
- Harmonized Structure (clauses 4–10) 9 questions
- Audit findings and nonconformities 8 questions
- Certification schemes and auditor registration 9 questions
5 Other ISO 13485 qualifications
- ISO 13485 Foundation / requirements 5 courses
- ISO 13485 Internal auditor 5 courses
- ISO 13485 Lead auditor 3 courses