Quality & Operational Excellence

Medical Device Quality Systems Awareness

Medical device manufacturers and suppliers must meet strict quality system requirements. This course provides awareness of medical device quality systems: ISO 13485, regulatory frameworks, design controls, risk management with ISO 14971, process validation, complaints and vigilance, post-market surveillance and supplier controls.

5 days Classroom or live online English

Smart Horizon Certified - Global Leadership Consultants

Take the course details with you.

Download the full standard outline: why attend, methodology, objectives, audience, competencies, the daily outline and current plans.

Download course PDF

Why attend

From knowledge to real-world impact.

Medical device quality failures can harm patients and halt market access. You will understand the key requirements and how they fit together.

Workplace challenges

Professional Problems This Course Is Designed to Solve

The programme explores practical approaches to the following challenges. Results depend on how the learning is applied in your organisation.

Difficulty translating subject knowledge into practical workplace decisions.
Inconsistent approaches to the activities covered in the course outline.
Lack of a structured plan for applying and reviewing new skills.

Course methodology

How you will learn.

Standard walkthroughs, case studies of recalls, risk management exercises and document reviews.

Course objectives

What you'll take away.

By the end of this course, participants will be able to:

Explain medical device regulatory frameworks
Understand ISO 13485 requirements
Describe design controls
Apply risk management principles
Understand process validation requirements
Manage complaints, vigilance and post-market surveillance

Target audience

Who should attend.

This course is suitable for:

Quality staff in medical device companies
Engineers and production staff
Suppliers to medical device manufacturers
Regulatory affairs staff
Auditors

Target competencies

Capabilities you will build.

Participants will develop competencies in:

Regulatory awareness
QMS requirements
Risk management
Validation
Post-market surveillance

Course outline

Your learning journey.

A focused, practical outline with time to explore, apply and reflect.

Day 1Medical Device Regulation

09:00–10:08Regulatory frameworks
10:08–11:00Device classification
11:00–11:30Coffee break
11:30–11:45Device classification (continued)
11:45–12:53Market access
12:53–14:00Exercise

Day 2ISO 13485

09:00–10:08Structure
10:08–11:00Key requirements
11:00–11:30Coffee break
11:30–11:45Key requirements (continued)
11:45–12:53Documentation
12:53–14:00Workshop

Day 3Design and Risk

09:00–10:08Design controls
10:08–11:00ISO 14971 risk management
11:00–11:30Coffee break
11:30–11:45ISO 14971 risk management (continued)
11:45–12:53Usability
12:53–14:00Exercise

Day 4Production

09:00–10:08Process validation
10:08–11:00Supplier controls
11:00–11:30Coffee break
11:30–11:45Supplier controls (continued)
11:45–12:53Traceability
12:53–14:00Case study

Day 5Post-Market

09:00–10:08Complaints
10:08–11:00Vigilance
11:00–11:30Coffee break
11:30–11:45Vigilance (continued)
11:45–12:53Post-market surveillance
12:53–14:00Action plan

The timings provided are estimates and may vary depending on the number of participants and the discussions taking place during the sessions. They are indicative only and do not constitute a binding commitment.

Dates & venues

Find a session that works for you.

Confirmed dates accept registration requests. Tentative dates are enquiry only.

Good to know

A few things to know.

How is the course delivered?

Our classroom programmes combine facilitated discussion, case studies, exercises and reflection. The precise format will be confirmed before enrolment.

Can you deliver this programme for our team?

Yes, you can enquire about a tailored programme. Share your goals, group size and preferred dates with our learning team.

Will I receive a certificate?

Participants who complete the programme receive a Smart Horizon UK certificate of attendance. Smart Horizon UK programmes are not externally accredited and do not award a professional qualification, licence or designation. Where a course title or outline refers to a professional certification (for example, AACE International's Certified Cost Professional), the programme supports learning and preparation only; the credential itself is awarded solely by the relevant professional body under its own application and examination requirements.

What should I confirm before booking travel?

Please confirm the session, exact venue, accessibility arrangements, fees and any visa requirements with the team before arranging travel. Tentative dates are not confirmed sessions.

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