Key course information
- Course learning format: IN-PERSON COURSE
- More course dates: See below or click 'Register'
- Pricing: click 'Register' to preview
- Course duration: Two Days
- Location: Shropshire, UK
- Interactive learning face-to-face with expert tutors
- Electronic course notes
- Gain CPD Credits: Smithers training is IOM3 Quality Assured and counts towards professional development.
To book, click Register and choose a session
Looking for an alternative format?
Upcoming online course dates
| Select a session when registering | |
|---|---|
| 24 - 25 June 2026 | |
| 30 September - 1 October 2026 | |
Course overview
This course introduces the key regulatory frameworks and standards governing medical devices in the EU and UK (Great Britain and Northern Ireland).
You’ll learn how requirements for safety, efficacy, compatibility and shelf life affect material selection and manufacturing processes for medical devices. The course also covers the application of quality systems (ISO 13485) and risk management principles (ISO 14971).
A detailed overview of plastics and rubber materials is included, focusing on biocompatibility, physical properties, sterilisation methods and packaging systems. By the end of the course, you’ll understand how regulatory, material and process factors interact in the design and production of compliant, high-performance medical devices.
Learning outcomes
By the end of this course, you will be able to:- Understand the scope of medical device regulation within the EU and UK.
- Determine classification rules and certification routes for medical devices.
- Apply the principles of ISO 13485 quality management and ISO 14971 risk management.
- Learn about sterilisation methods and their effects on plastics and rubber components.
- Select and interpret appropriate biocompatibility assessments (ISO 10993).
- Recognise how regulatory and process requirements influence material selection and manufacturing conditions.
Course content
This course covers the full pathway from regulatory compliance to material selection and packaging, providing a complete understanding of how medical device requirements influence the design, manufacture and performance of products made from plastics and rubber.EU and UK Medical Device Regulation
- Overview of regulatory frameworks, classification rules and certification routes for devices placed on the market in the EU and UK (Great Britain and Northern Ireland).
- Application of ISO 13485 requirements and their role in ensuring product consistency, traceability and compliance.
- Understanding ISO 14971 principles and how risk assessment influences design, material selection and manufacturing controls.
- Review of key international standards and biocompatibility testing approaches (ISO 10993) for plastics and rubber components.
- Guidance on selecting appropriate plastics and rubber materials based on performance, compatibility, processing and regulatory factors.
- Examination of common sterilisation processes and their effects on polymers used in medical devices.
- Overview of packaging requirements, materials and validation processes that ensure product integrity and shelf life.
Who should attend
This course is ideal for professionals involved in the design, manufacture or supply of medical devices made from plastics or rubber materials.
It will be particularly valuable for:
- Moulders and fabricators looking to supply the medical device sector who need an understanding of material, manufacturing and quality system requirements under the Medical Device Regulation (MDR).
- Existing suppliers and device manufacturers with limited experience in plastics or rubber who want to understand material-specific considerations, MDR scope and how these differ from traditional engineering materials.
Typical attendees include Technical Managers, Quality Managers, Design Engineers and Production Managers.
Meet your expert tutor
Dr Mohammed Alkattan – Consultant
With over 16 years’ experience in polymer science and biomaterials, Mohammed specialises in developing and commercialising advanced materials for medical and food-contact applications. A product development leader and consultant, he bridges the gap between R&D innovation and market-ready solutions, with expertise spanning hydrogels, biodegradable polymers and regulatory compliance.
What our delegates say about the course material
“Very helpful and professional, would recommend to others.”
James Wingham
(University of Sheffield)
“Useful with a lot of information”
Sara Pintado del Campe (GSK)
Contact us or download a brochure
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