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Course dates - click register to select dates
- 17 Mar - 14 Apr 25
- 07 Jul - 04 Aug 25
- 08 Sep - 06 Oct 25
- 10 Nov - 08 Dec 25
- We also run this course as an in-person event
Course details and format
- 6+ hours of recorded modules available
- 28 days to access course materials
- Optional live Q&A after course completion
- Electronic course notes
Course overview
This course provides an introduction to Medical Device regulations and product standards within the EU and UK (Great Britain and Northern Ireland).Regulatory requirements for safety, efficacy, compatibility and shelf life have an impact on material selection for medical devices and on their associated manufacturing processes - this course will help you understand the impacts and necessary considerations.
The course also covers the application of medical device quality systems and risk assessment.
You will also get an overview of different material types, with a focus on plastics and rubber - including discussion of the requirements for biocompatibility, physical properties, sterilisation and packaging systems.
Learning outcomes
- Gain an understanding of the scope of medical device regulation within the EU and UK
- Determine the classification rules and certification routes for medical devices
- Appreciate the application of the ISO13485 quality management system and the various approaches to risk management (ISO14971)
- Learn about different types of sterilisation process and their effect on products manufactured from plastics and rubber
- Discover how to select different options for biocompatibility assessment (ISO10993) and the interpretation of results
- Understand the impact on material selection and on manufacturing conditions for medical devices
Gain CPD credits
Smithers is an IOM3 Quality Assured training provider and our courses are approved towards professional development.
Course content
- EU and UK Medical Device Regulation (part 1)
- EU and UK Medical Device Regulation (part 2)
- Medical Device Quality Management System
- Medical Device Risk Assessment
- Medical Device Product Standards and Biocompatibility Assessment
- Materials Selection - Plastics
- Materials Selection - Rubber
- Sterilisation of Medical Devices
- Packaging systems for Medical Devices
Who will benefit
- Moulders and fabricators considering supplying medical device companies, typical roles may include: Technical Managers, Quality Managers, Others needing insight into the material and manufacturing and quality systems requirements and scope of MDR which may apply when making medical devices or medical grade materials.
- Existing suppliers or medical device manufacturers with little or no experience of engineering with plastics or rubber materials, typical roles may include: Designer/Engineers, Technical/Production managers, Others needing to understand the additional material specific considerations, the scope of the MDR in relation to their use and how these may differ from traditional engineering materials.
Presenter information
- Mohammed Alkattan (PhD)
What our delegates say about the course content
"Very helpful and professional, would recommend to others"James Wingham (University of Sheffield)
"Useful with a lot of information"
Sara Pintado del Campe (GSK)